Boston Scientific Recalls ESSENTIO MRI SR Pacemaker Due to Sensor Issues
Boston Scientific is recalling ESSENTIO MRI SR 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. Per the rubric, risk-of-harm products where injury has not yet been reported fall under the High severity category.
Plain-English summary
Boston Scientific Corporation is recalling the ESSENTIO MRI SR Pacemaker (Model L110). 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 devices were distributed nationwide in the United States, including all 50 states and Puerto Rico, as well as worldwide. The specific quantity of units affected is not stated in the source text.
Consumers and healthcare providers should contact Boston Scientific or their medical device representative for further instructions on how to proceed with the recall.
The recalled product
- Product
- ESSENTIO MRI SR 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 L110
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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