Boston Scientific Recalls VISIONIST CRT-P Pacemakers Due to Sensor Issues
Boston Scientific is recalling VISIONIST CRT-P 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. The hazard involves a sensor malfunction in a life-sustaining medical device, which poses a risk of harm, but the source text does not report any specific injuries, hospitalizations, or deaths, fitting the criteria for a High severity score.
Plain-English summary
Boston Scientific Corporation is recalling VISIONIST CRT-P Pacemakers, specifically Model U225 and Model 226. 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 total number of units affected or the number of patients impacted.
Consumers and healthcare providers should contact Boston Scientific or their healthcare provider for instructions on how to address this issue. The source text does not provide specific contact details or a deadline for action.
The recalled product
- Product
- VISIONIST CRT-P 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 U225 and Model 226
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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