Proponent pacemakers recalled for accelerated battery depletion risk
Boston Scientific has recalled certain Proponent pacemaker models worldwide. Hydrogen gas may accumulate inside the device, compromising the capacitor and causing accelerated 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: This is an FDA Class II recall of a critical medical device with a potential defect that could affect device function through accelerated battery depletion. No hospitalizations or injuries have been reported, placing it in the risk-of-harm category where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation has recalled multiple models of its Proponent pacemaker (Models L200, L201, L209, L210, L211, L221, and L231). The recall affects approximately 21,756 units distributed worldwide.
A latent defect allows small amounts of hydrogen to accumulate inside the pacemaker over time. This hydrogen can compromise the low-voltage capacitor, causing it to become electrically compromised. The result is accelerated battery depletion and abnormal progression of battery depletion indicators.
Patients with affected Proponent pacemaker models should consult their healthcare provider to determine if their device is included in this recall and to discuss any appropriate next steps.
The recalled product
- Product
- Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
- Manufacturer
- Boston Scientific Corporation
- Hazard
- hydrogen-release
- capacitor-failure
- battery-depletion
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) L200
- Serial Numbers: 464370
- 464446
- 464458
- 464460
- 464462
- 464468
- 464470
- 464475
- 464481
- 464482
- 464483
- 464490
- 464498
- 464500
- 464508
- 464512
- 464516
- 464519
- 464526
Distribution
Distribution scope not specified by the agency.
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