Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Boston Scientific COGNIS CRT-D Recalled by Boston Scientific CRM Corp Due to Boston Scientific identified a subset of COGNISTM CRT-Ds...

Date: September 17, 2014
Company: Boston Scientific CRM Corp
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific CRM Corp directly.

Affected Products

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.

Quantity: 31,144 total

Why Was This 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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Boston Scientific CRM Corp

Boston Scientific CRM Corp has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report