The Recall Desk
HighFDA (Devices)·Z-0026-2014·Announced 2013-10-23

Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion Risk

Boston Scientific is recalling TELIGEN implantable cardiac defibrillators 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 involves a high-risk medical device (ICD) where a defect could lead to premature battery depletion, posing a risk of harm, but the source text does not report any actual injuries or illnesses.

Plain-English summary

Boston Scientific CRM Corp is recalling TELIGEN implantable cardiac defibrillators (ICDs), specifically models E102 and E110, manufactured prior to December 2009. 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 a subset of these devices. Over time, this defect may cause increased current drain, which can lead to premature battery depletion. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.

Patients with these devices should contact their healthcare provider or Boston Scientific 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 F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for
Manufacturer
Boston Scientific CRM Corp
Category
Medical Device — Implantable Cardiac Defibrillator
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 E102
  • Serial Numbers: 000138
  • 000139
  • 000140
  • 000142
  • 000145
  • 000146
  • 000147
  • 000151
  • 000152
  • 000153
  • 000154
  • 000161
  • 000162
  • 000163
  • 000166
  • 000167
  • 000169
  • 000170
  • 000172

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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