Boston Scientific Recalls ACCOLADE MRI EL DR Pacemakers for Sensor Issues
Boston Scientific is recalling ACCOLADE MRI EL DR pacemakers due to 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 is classified as FDA Class II, and the hazard involves a sensor malfunction in a life-sustaining medical device. While no specific injuries or deaths are reported in the source text, the risk of harm from a pacemaker malfunction places this in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling the ACCOLADE MRI EL DR Pacemaker (Model L331). The recall was initiated after the company received 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 devices were distributed in all 50 U.S. states, Puerto Rico, and worldwide. The source text does not specify the exact number of units recalled or the specific dates of distribution.
Consumers who have this device implanted should contact their healthcare provider or Boston Scientific for further instructions. The source text does not provide specific consumer action steps beyond the general recall notice.
The recalled product
- Product
- ACCOLADE MRI EL DR 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 (1)
- Model L331
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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