Boston Scientific Recalls ESSENTIO MRI DR Pacemakers Due to Sensor Issues
Boston Scientific is recalling ESSENTIO MRI DR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
What this means for you
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 medical device malfunction (sensor over-sensing) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, placing it in the 'High' 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 ESSENTIO MRI DR Pacemaker (Model L111). 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 are distributed in all 50 U.S. states, Puerto Rico, and worldwide. The source text does not specify the total number of units affected or the specific dates of distribution.
Consumers with this device should contact their healthcare provider or Boston Scientific for instructions on how to proceed. The source text does not provide specific consumer action steps beyond the general recall notice.
The recalled product
- Product
- ESSENTIO MRI 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 L111
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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