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.
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: 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
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
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.
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