Recall Z-2558-2025— Boston Scientific Neuromodulation Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Neuromodulation Corporation, initiated 2025-07-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09. Reason: Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges..
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-08
- Firm location
- Valencia, CA, United States
Product description
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Reason for recall
Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges.
Data sourced from openFDA. This site is unofficial and independent of the FDA.