Boston Scientific INGENIO CRT-P Pacemakers Recalled for Battery Defect
Boston Scientific is recalling INGENIO CRT-P pacemakers that may develop high internal battery impedance, causing unexpected device resets and Safety Mode activation. Affected devices require replacement.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification applies due to potential loss of primary therapy from latent battery defect. While no illnesses have been reported, the risk of unexpected device malfunction in a life-sustaining cardiac device meets the criteria for Severe classification.
Plain-English summary
Boston Scientific Corporation is recalling certain INGENIO dual chamber pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) with Extended Life batteries. These devices may develop a latent battery condition characterized by high internal impedance that emerges later in device life, before the device reaches its normal end-of-life indicator.
When the battery exhibits high impedance, system resets may occur during telemetry attempts due to temporary high-power consumption. The device automatically activates Safety Mode to maintain backup pacing in response to these resets. Although pacing therapy continues during Safety Mode, the device malfunction requires replacement.
The recall affects 13,332 units distributed worldwide. Only INGENIO family pacemakers and CRT-Ps with Extended Life batteries are included in this recall. Specific serial numbers of affected devices are listed by model number in the FDA recall notice.
The recalled product
- Product
- INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
- Manufacturer
- Boston Scientific Corporation
- Hazard
- battery-defect
- system-reset
- device-failure
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)
- a) V172
- Serial Numbers: 100001
- 100003
- 100008
- 100011
- 100012
- 100026
- 100028
- 100032
- 100036
- 100039
- 100063
- 100066
- 100069
- 100070
- 100078
- 100084
- 100088
- 100094
- 100098
Distribution
Distribution scope not specified by the agency.
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