The Recall Desk
HighFDA (Devices)·Z-0025-2014·Announced 2013-10-23

Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion

Boston Scientific is recalling COGNIS CRT-D devices because a capacitor defect may cause premature battery depletion.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a life-sustaining medical device (CRT-D) where battery depletion could lead to a lack of pacing or defibrillation support, representing a significant risk of harm even though specific injury reports are not detailed in the provided text.

Plain-English summary

Boston Scientific CRM Corp is recalling the COGNIS CRT-D (Cardiac Resynchronization Therapy Defibrillator), models N118 and N119. The recall involves 38,500 units distributed worldwide, including the United States, Guam, Puerto Rico, and numerous international markets.

The recall is due to a potential performance issue with a low voltage capacitor in devices manufactured prior to December 2009. This defect may cause increased current drain over time, which can lead to premature battery depletion. The devices are indicated for patients at risk for sudden cardiac death due to ventricular arrhythmias who may require pacing support.

Affected patients should contact their healthcare provider or Boston Scientific for instructions on device monitoring and potential replacement. The specific serial numbers for models N118 and N119 are listed in the official FDA recall notice Z-0025-2014.

The recalled product

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. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5
Manufacturer
Boston Scientific CRM Corp
Category
Medical Device — Implantable Cardiac Device
Hazard
Affected units
38,500

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model N118
  • Serial numbers: 559191
  • 559192
  • 559195
  • 559196
  • 559200
  • 559201
  • 559202
  • 559203
  • 559210
  • 559211
  • 559212
  • 559215
  • 559222
  • 559223
  • 559225
  • 559226
  • 559231
  • 559232
  • 559236

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Boston Scientific CRM Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Boston Scientific CRM Corp

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Same hazard · battery depletion

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