Boston Scientific MRI PROPONENT SR Pacemaker Recall for Incorrect Literature Labeling
Boston Scientific is recalling five MRI PROPONENT SR pacemakers because the included literature incorrectly describes the device's pacing mode.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to incorrect documentation (literature packet) describing the pacing mode, which aligns with the rubric for minor labeling errors or voluntary precautionary recalls without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling five units of the MRI PROPONENT SR pacemaker, reference L210. These devices are used to treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy. The affected units have serial numbers 702961, 702963, 705644, 705666, and 705947.
The recall was initiated because the literature packet packaged with the devices incorrectly describes the pacemaker's pacing mode. Specifically, the literature may describe the pacemaker as SR when it is actually a DR pacemaker, or as DR when it is actually an SR pacemaker. This is a documentation error regarding the device's specifications.
The affected devices were distributed internationally to Colombia, Jamaica, and Trinidad & Tobago. The source text does not specify actions for consumers or patients, as the recall pertains to the accuracy of the accompanying documentation rather than a functional defect in the implanted device.
The recalled product
- Product
- Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Pacemaker
- Hazard
- Affected units
- 5
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)
- Serial numbers 702961
- 702963
- 705644
- 705666
- and 705947.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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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