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
- Affected units
- 21,756
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.
Part of a larger recall action
This product is one of 6 recalled by Boston Scientific Corporation 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 6 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- HighBoston Scientific Recalls Suture Cinch Endoscopic Tissue Approximation Devices
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus Recall
FDA (Devices) · 2026-08-26
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- SevereRadial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall
FDA (Devices) · 2026-08-12
Same hazard · hydrogen release
See all →- HighVALITUDE CRT-P Pacemaker Recalled Due to Potential Accelerated Battery Depletion
FDA (Devices) · 2021-07-14
- HighAltrua 2 Pacemakers at Risk from Hydrogen-Induced Battery Failure
FDA (Devices) · 2021-07-14
- HighEssentio Pacemaker Models Recalled for Potential Battery Depletion Risk
FDA (Devices) · 2021-07-14