Boston Scientific Recalls VALITUDE CRT-P Pacemakers Due to Sensor Issues
Boston Scientific is recalling VALITUDE CRT-P pacemakers due to reports of intermittent over-sensing of the Minute Ventilation sensor signal.
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 medical device that could impact patient care, fitting the 'High' severity criteria for risk-of-harm products where specific injury reports are not detailed in the provided text.
Plain-English summary
Boston Scientific Corporation is recalling VALITUDE CRT-P Pacemakers (Model U125). 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 source text does not specify the exact 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 source text does not provide specific consumer action steps beyond the general context of a recall.
The recalled product
- Product
- VALITUDE 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 U125
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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