Boston Scientific Recalls ALTRUA 2 SR Pacemakers Due to Sensor Issues
Boston Scientific is recalling ALTRUA 2 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 medical device with a functional defect (sensor over-sensing) that poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling ALTRUA 2 SR Pacemakers (Model S701). 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 in all 50 U.S. states, Puerto Rico, and worldwide. The source text does not specify the number of units affected or the specific dates of distribution.
Consumers with these devices should contact their healthcare provider or Boston Scientific for further instructions on how to proceed.
The recalled product
- Product
- ALTRUA 2 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 S701
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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