Boston Scientific Recalls VALITUDE X4 CRT-P Pacemakers Due to Sensor Issues
Boston Scientific is recalling VALITUDE X4 CRT-P 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 is classified as FDA Class II, and the hazard involves a sensor malfunction in a life-sustaining medical device where injury has not yet been explicitly reported in the provided text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Boston Scientific Corporation is recalling VALITUDE X4 CRT-P Pacemakers (Model U128). 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 have been 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.
Patients with these devices should contact their healthcare provider for further instructions. The source text does not provide specific consumer action steps beyond the general context of a medical device recall.
The recalled product
- Product
- VALITUDE X4 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 U128
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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