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IMPORTANT PRODUCT INFORMATION

We pursue excellence in every product we make. We have a strong history of product safety and reliability, and we remain dedicated to developing technology and products that save and improve the lives of patients worldwide.

We take our responsibilities as a leading device manufacturer very seriously and recognize our primary responsibility is to ensure that our devices are of the highest quality and function safely and properly.

Our commitment to business integrity means we quickly share with professionals and patients the important information they need about our products’ performance and safety. These product advisories and communications remain available for review.

Medical Device Correction: Merlin Patient Care System (PCS) - February 28, 2020

An important medical device correction notice communicating that Merlin™ PCS V24.6.1 contains an anomaly that may result in specific programming changes not being stored in the device. We have proactively reviewed 100% of patient records and confirmed there is no impact to patients, and no intervention is needed.

Physician communication – Merlin Patient Care System (PCS) Software Version 24.6.1 Anomaly

Voluntary Recall: Specific Lots of Coronary Catheters - January 29, 2020

A field safety notice (FSN) was issued on Jan. 29, 2020, to physicians and hospitals who received coronary-specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm and 5.0mm.

Physician Communication – Field Safety Notice for Coronary Dilatation Catheters

Medical Device Correction: Ellipse Implantable Cardioverter Defibrillator (ICD) Radio Frequency - January 22, 2020

An important medical device correction notice communicating that a small number of Ellipse™ devices may lose wireless radiofrequency (RF) communication following a recent device software update.

Physician Communication – Ellipse ICD Radio Frequency

Urgent Medical Device Recall: HeartMate Mobile Power Unit with HeartMate 3 LVAS - December 2, 2019

An urgent medical device recall notice regarding interference of static electricity with the HeartMate Mobile Power Unit™ when used with HeartMate 3™ Left Ventricular Assist System.

Physician Communication – HeartMate Mobile Power Unit Model 107754 with HeartMate 3 LVAS Model 106524US

Urgent Medical Device Recall: CentriMag Acute Circulatory Support System - August 22, 2019

An urgent medical device recall notice to customers communicating that we have received reports of CentriMag™ Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).

Physician Communication – CentriMag Acute Circulatory Support System Motor Model 102956

Urgent Medical Device Recall: Ellipse Implantable Cardioverter Defibrillator (ICD) Latent Electronics Vulnerability – June 20, 2019

A product recall and a subsequently provided urgent medical device recall notice communicating patient management recommendations for a small number of Ellipse implantable cardioverter defibrillators which may be subject to a latent vulnerability in the electronics circuitry.

Physician Communication – Ellipse ICD Models CD1411-36Q, CD2411-36Q, CD2411-36C

Urgent Medical Device Recall: HeartMate 3 Outflow Graft Leak (C-Ring) – March 30, 2019

An urgent medical device recall notice communicating reports of the HeartMate 3 Outflow Graft leaking at its pump connection during implantation because the Screw Ring either disconnected or did not tighten completely. The information below includes patient management recommendations.

Physician Communication – HeartMate 3 Outflow Graft Leak (C-Ring)

Urgent Medical Device Recall: HeartMate Coring Tool with Black Particle From Blade Cover – March 7, 2019

An urgent medical device recall notice communicating that a physician observed a small black plastic particle in the left ventricle during the implant procedure after using the HeartMate 3 Coring Tool. Investigation into this issue has confirmed that the particle came from the Coring Tool’s plastic blade cover.

Physician Communication – HeartMate 3 Coring Tool with Black Particle from Blade Cover


Product Advisory Archive

Urgent Medical Device Correction: Confirm Rx ICM Inability to Pair the Implanted Device – November 2018

An urgent medical device correction notice communicating a voluntary recall of a small number of Confirm Rx™ Insertable Cardiac Monitors (ICM) subject to a communication issue resulting in the inability to pair the implanted device with the mobile phone app.

Physician Communication – Confirm Rx Insertable Cardiac Monitor Model DM3500 Inability to Pair the Implanted Device

Urgent Medical Device Recall: HeartMate 3 Left Ventricular Assist System – October 17, 2018

An update to the previously communicated Class I Recall associated with the HeartMate 3 Left Ventricular Assist System. We have received FDA approval for the Outflow Graft Clip, designed to prevent any rotation of the outflow graft, thus addressing the safety concern reported in the May 2018 notice. The Outflow Graft Clip is now available.

Physician Communication – HeartMate 3 Left Ventricular Assist System Outflow Graft Twist Occlusion Model 106524 LVAS Kit, HM3; 10012390GBL

 

On May 22, 2018, the FDA classified this medical device advisory as a Class I Recall. We provided a frequently asked questions document for physician use as needed, to cover the most common questions relating to the HeartMate 3 Left Ventricular Assist System recall.

Physician Communication, May 24, 2018 – HeartMate 3 Left Ventricular Assist System Outflow Graft Twist Frequently Asked Questions

 

On May 21, 2018, we provided an update to the important medical device advisory regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.

Physician Communication, May 21, 2018 – HeartMate 3 Left Ventricular Assist System Outflow Graft Twist Occlusion Model 106524 LVAS Kit, HM3; 10012390GBL Updated Important Medical Device Advisory

 

On April 5, 2018, we provided an important medical device advisory regarding the HeartMate 3 Left Ventricular Assist System in which certain patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm.

Physician Communication, April 5, 2018 – HeartMate 3 Left Ventricular Assist System Outflow Graft Twist Occlusion Model 106524 LVAS Kit, HM3; 10012390GBL Important Medical Device Advisory

Urgent Medical Device Recall: CentriMag Acute Circulatory Support System – September 5, 2018

An urgent medical device recall notice to customers communicating that we have received reports where damage to the cable that connects the motor to the console resulted in interruption of active support. This communication is to remind our physician and hospital partners of the importance of following the proper method for exchanging the CentriMag Acute Circulatory Support System Motor Model 102956 in the event the system experiences an interruption of power.

Physician Communication – CentriMag Acute Circulatory Support System Motor Model 102956

Physician Communication – CentriMag Acute Circulatory Support System Corrective Action Frequently Asked Questions

Urgent Medical Device Recall: CardioMEMS Hospital and Patient Electronics System – June 14, 2018

An urgent medical device recall notice to hospitals, clinics and patients communicating that a small number of CardioMEMS Hospital Electronics Systems Model CM3000 and Patient Electronics Systems Model CM1100 may deliver a false Error 5 message due to an incorrectly configured component within the device electronics.

Patient Frequently Asked Questions, June 15, 2018 – CardioMEMS Hospital and Patient Electronics System Error 5

Patient Letter, June 15, 2018 – CardioMEMS Hospital and Patient Electronics System Error 5

Hospital Frequently Asked Questions, June 15, 2018 – CardioMEMS Hospital and Patient Electronics System Error 5

Hospital Letter, June 14, 2018 – CardioMEMS Hospital and Patient Electronics System Error 5

Urgent Medical Device Correction: Confirm Rx ICM with Incorrect Low Battery Indicators Due to Cold Temperature – May 18, 2018

We notified physicians that exposure to sub-freezing temperatures during our supply chain process caused a transient battery voltage drop for a small number of Confirm Rx Insertable Cardiac Monitoring (ICM) Model DM3500 devices. Updated Merlin programmer software will be made available to allow physicians to detect the presence of an incorrect low battery indicator prior to implant and provide a mechanism to resolve the incorrect display for already implanted devices.

Physician Communication – Confirm Rx Insertable Cardiac Monitor with Incorrect Low Battery Indicators Due to Cold Temperature

Medical Device Advisory: Implantable Cardioverter Defibrillator Cybersecurity Firmware Update – April 16, 2018

On November 22, 2019, we recently completed an analysis of over 400,000 patient device cybersecurity firmware updates. This real-world data set provides an update to the risk profile associated with executing cybersecurity firmware updates.

Physician Communication – Clinical Update

 

On April 16, 2018, we notified physicians about the availability of new device firmware to further strengthen the security and improve the performance of our high voltage (HV) implantable cardiac devices (ICDs and CRT-Ds). The firmware upgrade includes improved cybersecurity protection and an update to provide device based premature battery depletion detection in certain HV devices.

Physician Communication – Battery Performance Alert and Cybersecurity Firmware Upgrade for Certain ICD and CRT-D Devices

Medical Device Advisory: Premature Battery Depletion with Implantable Cardioverter Defibrillator – April 16, 2018

We recently notified physicians about the availability of new device firmware to further strengthen the security and improve the performance of our high voltage (HV) implantable cardiac devices (ICDs and CRT-Ds).

As communicated in August 2017, the Battery Performance Alert (BPA) algorithm is a management tool and is intended to provide earlier notification of abnormal battery performance for Battery Advisory Devices prior to premature battery depletion. Until now, detection of this alert has only been available through the Merlin.net™ remote monitoring system and the Merlin programmer during routine follow-up evaluations. This firmware upgrade now allows for device-based detection of abnormal battery performance and if BPA is triggered, a vibratory notification is delivered to the patient, thereby ensuring continuous monitoring in situations where adherence to transmission schedules is challenging (e.g. travel). Additionally, an alert will still continue to be provided to physicians through the Merlin.net remote monitoring system and the Merlin programmer during subsequent follow-up.

Physician Communication – Battery Performance Alert and Cybersecurity Firmware Upgrade for Certain ICD and CRT-D Devices

Physician Communication – Battery Performance Alert White Paper

 

We developed online information for patients. This page includes important information about the update and responses to frequently asked questions from patients.

Cybersecurity Update Information for Patients

On August 29, 2017, as part of our commitment to continuous improvement, we have recently released an update intended to provide physicians with earlier warning of the potential for premature battery depletion due to short circuits from lithium clusters in patients’ implantable defibrillators.

The new Battery Performance Alert, which can be used as a patient management tool and is intended to help identify potential premature battery depletion in the following devices subject to the October 11, 2016 Medical Device Advisory: Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™.

Physician Communication – Battery Performance Alert Field Safety Notice Update

 

On October 11, 2016, we provided an important medical device advisory to physicians regarding ICD and CRT-D devices manufactured before May 23, 2015 for models Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra.

Physician Communication, October 19, 2018 – ICD Premature Battery Depletion Advisory Update

Physician Communication, October 11, 2016 – Premature Battery Depletion with Implantable Cardioverter Defibrillator

Physician Communication, October 11, 2016 – For Reference, Programmed Parameters for ERI Example

Physician Communication, October 2016 – Estimated Performance of Affected ICD and CRT-D Devices

Medical Device Information: Nanostim Leadless II IDE/CAP Study – April 5, 2018

On April 16, 2018, we developed online information for patients. This page includes important information about the new Battery Performance Alert update and responses to frequently asked questions. Patients can also look up their serial numbers for their devices and learn more about remote monitoring options.

Battery Performance Information for Patients

On April 5, 2018, we provided an update regarding the investigation of the Nanostim™ Leadless Cardiac Pacemaker Study (LCP) detached docking button.

Physician Communication – Nanostim Leadless II IDE/CAP Study Pause Update

 

On November 17, 2017, we provided a communication to physicians regarding the Nanostim™ Leadless Cardiac Pacemaker.

Physician Communication – Nanostim Leadless Cardiac Pacemaker

Safety Notice: Pacemaker Cybersecurity Firmware Update – August 29, 2017

November 22, 2019 – Abbott recently completed an analysis of over 400,000 patient device cybersecurity firmware updates. This real-world data set provides an update to the risk profile associated with executing cybersecurity firmware updates.

Physician Communication – Clinical Update

 

On August 29, 2017, Abbott provided an update to physicians with information on a pacemaker firmware update for Abbott pacemaker models which include the RF telemetry versions of the following devices in the U.S.: Accent SR RF™, Accent MRI™, Assurity™, Assurity MRI™, Accent DR RF™, Anthem RF™, Allure RF™, Allure Quadra RF™ and Quadra Allure MP RF™.

Physician Communication – Pacemaker Firmware Field Safety Notice

Watch the low voltage device firmware cybersecurity update – this video will review the steps to update the device firmware.

Abbott has developed online information for patients. This page includes important information about the update and responses to frequently asked questions from patients.

Cybersecurity Update Information for Patients

Medical Device Information: Nanostim Leadless II IDE/CAP Study – October 28, 2016

On October 28, 2016, we provided an important medical device information communication to physicians regarding the Nanostim™ Leadless II IDE/CAP Study.

Physician Communication – Nanostim Leadless II IDE/CAP Study

Medical Device Advisory: Optisure Dual Coil HV Leads – November 3, 2015

On January 22, 2016, we provided an important medical device advisory update regarding the Optisure™ Dual Coil HV Leads.

Physician Communication, January 22, 2016 – Optisure Dual Coil HV Leads Update

 

On November 3, 2015, we provided an important medical device advisory regarding the Optisure Dual Coil HV Leads.

Physician Communication, November 3, 2015 – Optisure Dual Coil HV Leads

Considerations: Older Generation Pacemakers – January 29, 2014

Considerations When Using Electrocautery in Patients Implanted with Older Generation St. Jude Medical™ Pacemakers (Affinity™, Entity™, Integrity™, Identity™, Sustain™, Frontier™, Victory™ and Zephyr™ models).

Physician Communication – Considerations When Using Electrocautery in Patients Implanted with Older Generation Pacemakers

Medical Device Advisory: Ellipse and Ellipse ST VR/DR ICD – August 19, 2014

On August 19, 2014, we provided an important medical device advisory regarding the Ellipse™ and Ellipse™ ST VR/DR Implantable Cardioverter Defibrillators (ICDs).

Physician Communication – Ellipse and Ellipse ST VR/DR ICD

Patient Communication – Ellipse Implantable Cardioverter Defibrillators

Medical Device Correction: Merlin@home RF Remove Monitoring Transmitter – December 18, 2014

On December 18, 2014, we provided an important medical device correction to physicians regarding the Merlin@home™ RF Remote Monitoring Transmitter Model EX1150.

Physician Communication – Merlin@home RF Remote Monitoring Transmitter

 

On August 18, 2015, we provided an important medical device correction update regarding the Merlin@home RF Monitoring Transmitter Model EX1150.

Physician Communication – Potential for Backup Operation of an Implantable Device as a Result of Interaction with a Merlin@home RF Remote Monitoring Transmitter Update

Medical Device Advisory: QuickSite and QuickFlex LV CRT Leads – April 4, 2012

On April 3, 2012, we provided a medical device advisory and important product information update regarding the QuickSite™ and QuickFlex™ LV CRT leads.

Physician Communication – Important Product Information Update QuickSite and QuickFlex LV CRT Leads

Physician Communication – Lead Update QuickSite and QuickFlex LV CRT Leads

 

QuickFlex™ µ and Quartet™ Optim™ insulated leads are not included in this advisory.

QuickFlex™ µ and Quartet™ Optim™ insulated LV CRT leads have demonstrated superior performance during the approximately three years they have been on the market. There have been zero reports of externalized conductors in QuickFlex µ and Quartet Optim LV CRT leads, and they continue to demonstrate excellent performance by any measure.

All QuickFlex µ and Quartet Optim insulated LV CRT leads are constructed with full-body Optim™ insulation, a material shown to be 50 times more abrasion resistant than silicone insulation.¹

Important Information: Amplatzer Septal Occluder (ASO) – May 24, 2012

AMPLATZER Septal Occluder (ASO) FDA Panel Review Materials

The FDA occasionally invites medical manufacturers to review device performance in a public forum to determine if any changes are needed for device labeling or whether any additional data needs to be collected to better understand device performance. St. Jude Medical was invited to the Circulatory System Devices Panel of the Medical Devices Advisory Committee for discussion on May 24, 2012.

Supporting Materials

Supporting documents for the FDA panel provided by St. Jude Medical include:

The American College of Cardiology (ACC) guidelines focus on assisting healthcare providers in clinical decision making, defining practices that meet the needs of most patients in most circumstances and supporting the practicing cardiologist in the care of adult congenital heart disease (ACHD) patients:

ACC/AHA Guidelines for the Management of Adults with Congenital Heart Disease

 

The ACC guidelines focus on assisting healthcare providers in clinical decision making, defining practices that meet the needs of most patients in most circumstances and supporting the practicing cardiologist in the care of pediatric patients with congenital heart disease.

Indications for Cardiac Catheterization and Intervention in Pediatric Cardiac Disease

 

The AMPLATZER Septal Occluder Delivery System Instructions for Use (IFU) was updated in January 2012.

AMPLATZER Septal Occluder and Delivery System Instructions for Use

ASO Clinical Experience

 

AMPLATZER™ Septal Occluder (ASO) Instructions For Use Updates

This letter is to inform physicians about important information concerning the AMPLATZER Septal Occluder instructions for use.

AMPLATZER Septal Occluder Physician Letter

Product Performance Information: Riata and Riata ST Silicone Defibrillation Leads

We voluntarily and proactively stopped selling our Riata™ and Riata ST Silicone Defibrillation Leads in December 2010. Find more information here.

Important Device Upgrade Information: Epic and Atlas ICDs – January 16, 2008

We are making a programmer software upgrade available to resolve and eliminate a very rare occurrence (incidence of 8 in 143,000 devices) that could lead to a ventricular sensing anomaly in our Epic™ and Atlas™ families of Implantable Cardioverter Defibrillators (ICDs). The new programmer software (version 6.4.1 for Merlin PCS and version 6.5.1 for Model 3510) will allow a programmer to automatically identify a device that can benefit from a firmware upgrade to resolve and eliminate the potential issue with a simple, one-time device software upgrade.

St. Jude Medical Field Sales Staff and Field Clinical Engineers will install this software upgrade in Merlin™ PCS and Model 3510 programmers in the field. Thereafter, upon initial interrogation of an Epic or Atlas family ICD, the Merlin or 3510 programmer will automatically identify implanted devices that require a firmware upgrade and will inform the clinician with a message that an upgrade should be performed. The programmer will complete the device upgrade in approximately 10-20 seconds. During the upgrade process the device continues to function as programmed, with all bradycardia and tachycardia functions fully available.

Approximately 143,000 Epic and Atlas family ICDs have been implanted worldwide since July 2002; approximately 123,000 of these devices remain in service. To date, 8 out of 143,000 of the subject device population (an incidence of 0.00006) have been found to exhibit a loss of ventricular sensing, with a risk of patient harm estimated to be on the order of 1 in 1 million (0.000001).

The loss of ventricular sensing has been attributed to a well defined, yet extremely rare timing sequence that occurs in a very small (61 microsecond) timing window. No patient injuries or deaths have been reported to St. Jude Medical as the result of a device entering the described loss of sensing state. As mentioned above, the potential issue can be fully resolved and eliminated by a programmer initiated upgrade to the device.

In summary:

A simple programmer software/device firmware upgrade will resolve the issue and prevent a future occurrence. Patients who are followed on a routine basis with scheduled follow-up visits every three to six months should continue with their scheduled visit. Upon interrogation of one of the subject devices, the Merlin and Model 3510 programmers with the newly provided software will automatically identify a device that can benefit from a firmware upgrade and will instruct the clinician that an upgrade is available.

We, along with our independent Medical Advisory board members have determined that no other action is recommended.

REFERENCES

1. Jenney, C., Tan, J. Karicherla, A., Burke, J., & Helland, J. (2005) A new insulation material for cardiac leads with potential for improved performance. Heart Rhythm, 2(Suppl. 5), S318-S319. http://dx.doi.org/10.1016/j.hrthm.2005.02.1004

 

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.