Boston Scientific Recalls ESSENTIO SR Pacemakers Due to Sensor Signal Issues
Boston Scientific is recalling ESSENTIO SR Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
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 involves a risk-of-harm product where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Boston Scientific Corporation is recalling ESSENTIO SR Pacemakers (Model L100). The recall was initiated after the company received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal in certain pacemaker and cardiac resynchronization therapy pacemaker systems.
The affected devices are distributed across all 50 U.S. states, Puerto Rico, and worldwide. The specific hazard involves the Minute Ventilation sensor potentially over-sensing signals, which could affect the device's performance.
Consumers with these devices should contact their healthcare provider or Boston Scientific for further instructions on how to proceed.
The recalled product
- Product
- ESSENTIO 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 L100
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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