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Ellipse

Implantable Cardioverter Defibrillator

Product Advisories

Product Advisories

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.

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).

MAT-2011536 v1.0

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CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

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MAT-1900882 v12.0