The Recall Desk
HighFDA (Devices)·Z-0088-2015·Announced 2014-10-29

Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion

Boston Scientific is recalling TELIGEN ICDs and COGNIS CRT-Ds due to a capacitor defect that may cause the battery to deplete prematurely.

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 involves an implantable medical device with a defect that leads to premature battery depletion. This is a risk-of-harm product where the failure of a life-sustaining device could result in serious injury or death, but the source text does not explicitly report specific injuries or fatalities, placing it in the 'High' category per the rubric.

Plain-English summary

Boston Scientific CRM Corp is recalling a subset of COGNIS CRT-Ds and TELIGEN Implantable Cardiac Defibrillators (ICDs). The recall is due to compromised performance of a low voltage (LV) capacitor, which has been identified as causing an increased rate of premature battery depletion in these devices.

The affected devices include TELIGEN ICD models E102 and E110, as well as specific COGNIS CRT-D models. The source text notes that models E103, E111, F102, F103, F110, and F111 are not available in the US. A total of 31,144 devices are involved in this recall. The devices were distributed worldwide, including nationwide in the US and in numerous countries outside the US.

Boston Scientific updated a physician communication from August 2013 to include additional devices that may experience this issue. Patients with these devices should contact their healthcare provider to determine if their specific device is affected and to discuss appropriate monitoring or replacement options.

The recalled product

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 defibrillator
Manufacturer
Boston Scientific CRM Corp
Category
Medical Device — Implantable Cardiac Defibrillator
Hazard
Affected units
31,144

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 E102 - Serial Numbers: 240307
  • 240308
  • 240310
  • 240312
  • 240313
  • 240318
  • 240319
  • 240320
  • 240321
  • 240324
  • 240325
  • 240326
  • 240327
  • 240329
  • 240330
  • 240332
  • 240336
  • 240338
  • 240340
  • 240342

Distribution

Distributed nationwide across the United States.

The notice also names 4 states 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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