Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2558-2025 — Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09

U.S. FDA — Device Enforcement · United States · 2025-07-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2558-2025
Date of alert
2025-07-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Neuromodulation Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
08714729985044
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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