Recall Z-0088-2015— Boston Scientific CRM Corp

Class II FDA medical device recall by Boston Scientific CRM Corp, initiated 2014-09-17, terminated 2015-02-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This 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. Reason: 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.

Recalling firm

Boston Scientific CRM Corp

Classification

Class II

Status

Terminated

Initiated

2014-09-17

Terminated

2015-02-20

Firm location

Saint Paul, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.