Boston Scientific Recalls ESSENTIO EL DR Pacemakers Due to Sensor Issues
Boston Scientific is recalling ESSENTIO EL DR pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
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 involves a medical device with a functional defect (sensor over-sensing) that poses a risk of harm, but the source text does not report specific injuries, hospitalizations, or fatalities, nor does it classify the recall as FDA Class I.
Plain-English summary
Boston Scientific Corporation is recalling ESSENTIO EL DR pacemakers (Model L121). The recall is being conducted because the company has 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 specific quantity of units affected is not stated in the source text.
Consumers with these devices should contact their healthcare provider or Boston Scientific for further instructions regarding the recall and potential replacement or repair.
The recalled product
- Product
- ESSENTIO 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 L121
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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