The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-3256-2018·Announced 2018-10-03

Boston Scientific Recalls PROPONENT Pacemakers Due to Battery Depletion

Boston Scientific is recalling PROPONENT pacemakers because hydrogen exposure may cause the battery to deplete faster than expected, requiring early replacement.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe (4). While the source text does not explicitly mention hospitalizations, the potential for early battery depletion in a life-sustaining device like a pacemaker represents a significant risk that aligns with the 'Severe' criteria for Class II recalls involving critical functionality.

Plain-English summary

Boston Scientific Corporation is recalling a subset of active PROPONENT pacemaker and CRT-P systems. The recall is due to an identified issue where hydrogen exposure can lead to accelerated battery depletion, resulting in the need for early pacemaker replacement.

The affected devices include the PROPONENT SR model L200, PROPONENT MRI models L201, L211, and LL231, and the PROPONENT EL DR model L221. These devices were distributed in numerous states across the United States, including Alaska, Alabama, Arizona, California, and others, as well as Puerto Rico.

Patients with these specific pacemaker models should contact their healthcare provider to discuss the recall and determine if a replacement is necessary. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
PROPONENT Pacemaker
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Pacemaker
Hazard

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 (5)

  • PROPONENT SR model L200
  • PROPONENT MRI models L201
  • L211
  • and LL231
  • and PROPONENT EL DR model L221.

Distribution

Distributed in 48 states:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

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