Recall Z-0087-2015— 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 COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.. 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.