Boston Scientific Recalls VISIONIST X4 CRT-P Pacemakers Due to Sensor Issues
Boston Scientific is recalling VISIONIST X4 CRT-P Pacemakers because the Minute Ventilation sensor may intermittently over-sense signals.
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 medical device malfunction (sensor over-sensing) which poses a risk of harm, but no injuries or illnesses are explicitly reported in the source text.
Plain-English summary
Boston Scientific Corporation is recalling the VISIONIST X4 CRT-P Pacemaker (Model U228). 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 specific dates of distribution.
Consumers with this device should contact their healthcare provider or Boston Scientific for instructions on next steps. The source text does not provide specific consumer action instructions beyond the recall notice itself.
The recalled product
- Product
- VISIONIST 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 U228
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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