Reported Oct 29, 2014 · Terminated
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available…
Boston Scientific CRM Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific CRM Corp · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following
- models are not available in the US
models E103E111F102F103F110F111. Sterilized using ethylene oxide
- Product UsageThis family of implantable cardioverter defibrillators (ICDs) provide
- a variety of therapies including-Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
- Lot codes and dates
- Model E102 - Serial Numbers
4,071 of 4,071 codes
240307240308240310240312240313240318240319240320240321240324240325240326240327240329240330240332240336240338240340240342240344240345240346240348240349240350240351240354240355240356240358240359240360240363240365240366240367240368240369240371240372240373240374240375240376240378240380240383240384240386240389240391240393240397240398240399240401240403240404240405
- Model E102 - Serial Numbers
- Amount recalled
- 31,144 devices total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due to compromised performance of a low volt
This product could cause temporary or reversible health problems — stop using it.
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