The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1999-2021·Announced 2021-07-14

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category
Medical Device — Cardiac / Pacemaker
Hazard
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 →

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