Boston Scientific Recalls Three Pacemakers Due to Incorrect Literature Packet
Boston Scientific is recalling three PROPONENT MRI DR pacemakers because the included literature packet incorrectly describes the device type.
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 2/5 (Moderate).
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, and the hazard is a documentation error (mis-labeling) without reported injuries or illnesses, fitting the Moderate severity criteria for minor labeling errors.
Plain-English summary
Boston Scientific Corporation is recalling three PROPONENT MRI DR pacemakers, reference number L211. These devices are used to treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy. The specific units involved have serial numbers 209409, 209518, and 209609.
The recall was initiated because the literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker, or as DR when it is actually an SR pacemaker. This documentation error could lead to confusion regarding the specific pacing mode of the implanted device.
The affected devices were distributed internationally to Colombia, Jamaica, and Trinidad & Tobago. Patients with these specific serial numbers should contact their healthcare provider or Boston Scientific for further instructions regarding the documentation discrepancy.
The recalled product
- Product
- Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. 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
- 3
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 (3)
- Serial numbers 209409
- 209518
- and 209609.
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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