Deep brain stimulation implant manuals recalled after wire breaks in generators
The Vercise Deep Brain Stimulation Systems Surgical Implant Manual is being recalled after wire breaks in rechargeable pulse generators implanted in the submuscular pectoral location. 25,260 units are affected.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; wire breaks that end stimulation and require replacement surgery are a potential harm and no injuries are reported.
Plain-English summary
The Vercise Deep Brain Stimulation Systems Surgical Implant Manual, document number 92328632-09 Rev A, UDI-DI 08714729985044 and 08714729985051, is being recalled. The recall covers 25,260 units distributed nationwide in the United States and internationally.
Wire breaks have occurred in rechargeable deep brain stimulation implantable pulse generators implanted in the submuscular pectoral location. The manufacturer states that wire breaks prevent successful stimulation, requiring device removal or replacement, and that users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges. The FDA classified the action as Class II.
Surgical teams should follow the manufacturer's updated implant manual. Patients with an implanted system who notice a change in therapy should contact their treating clinician.
The recalled product
- Product
- Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- Hazard
- wire-break
- loss-of-therapy
- deep-brain-stimulation
- class-ii
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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