Boston Scientific INLIVEN CRT-P Pacemakers Battery Impedance Recall
Boston Scientific recalls dual chamber INGENIO family pacemakers and CRT-Ps with Extended Life batteries that may develop high internal impedance, causing Safety Mode and system resets, requiring device 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 requires minimum severity score of 4. Although no illnesses or injuries have been reported, the latent battery malfunction poses inherent patient safety risk through potential system resets, even with maintained backup pacing capability.
Plain-English summary
Boston Scientific Corporation is recalling certain dual chamber INGENIO family pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) with Extended Life batteries. The affected models are V284, V285, W274, and W275, with approximately 3,634 units distributed worldwide.
These devices may initiate Safety Mode later in their operational lifespan, before the battery reaches the explant indicator. This occurs when the device's battery develops high internal impedance. This latent condition creates a risk for system resets due to temporary high-power consumption from telemetry attempts, after which the device reverts to Safety Mode to maintain backup pacing.
Although therapy is still provided when a device is in Safety Mode, replacement of the device is required. The recall affects only dual chamber INGENIO family models with the Extended Life battery design.
The recalled product
- Product
- INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemaker
- Hazard
- battery-impedance
- system-reset
- pacemaker-malfunction
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) V284
- Serial Numbers: 100002
- 100000
- 100003
- 100005
- 100009
- 100010
- 100011
- 100012
- 100014
- 100015
- 100016
- 100017
- 100018
- 100019
- 100022
- 100023
- 100027
- 100029
- 234350
Distribution
Distribution scope not specified by the agency.
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