Vercise Deep Brain Stimulation Systems Recall Due to Wire Breaks
Boston Scientific is recalling Vercise Deep Brain Stimulation Systems due to wire breaks in implanted pulse generators that prevent therapy. Device removal and replacement is typically required.
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: This Class II recall involves actual device failures in an implanted medical device critical to patient therapy. While no injuries have been reported, wire breaks that prevent therapy and require device removal represent a significant risk of harm to patients dependent on deep brain stimulation.
Plain-English summary
Boston Scientific Neuromodulation Corporation is recalling Vercise Deep Brain Stimulation Systems Surgical Implant Manual (Document Number 92328632-09). Approximately 25,260 units have been distributed worldwide, including throughout the United States and internationally.
Wire breaks have occurred in rechargeable implantable pulse generators implanted in the submuscular pectoral location. These wire breaks prevent successful delivery of stimulation therapy, requiring device removal and replacement.
Patients with affected devices may experience loss of therapy, return of symptoms, high monopolar impedances, undesired sensations, and Bluetooth connectivity challenges.
The recalled product
- Product
- Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Hazard
- wire-break
- therapy-loss
- device-failure
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 (3)
- UDI-DI: 08714729985044
- 08714729985051. Document Number/Revision: 92328632-09
- Rev A
Distribution
Distributed nationwide across the United States.
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