Boston Scientific Recalls PROPONENT MRI Pacemakers Due to Sensor Signal Issues
Boston Scientific is recalling PROPONENT MRI Pacemakers because of reports of intermittent over-sensing of the Minute Ventilation sensor signal.
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: The recall involves a medical device with a functional defect (sensor over-sensing) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling PROPONENT MRI Pacemakers. The recall is due to reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal in certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems.
The affected products include models L210, L211, and L231, which are noted as not approved in the US. The distribution pattern lists numerous US states, Puerto Rico, and worldwide locations.
Consumers and healthcare providers should contact Boston Scientific for further instructions regarding the recall and potential replacement or repair of the devices.
The recalled product
- Product
- PROPONENT MRI 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 (4)
- Model's
- L210
- L211
- and L231 - NOT APPROVED IN US
Distribution
Part of a larger recall action
This product is one of 24 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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