Vercise™ DB-9208-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191506014339), received between Feb 18, 2026 and Feb 18, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “High impedance” (1 report).

4 other recalls cover devices cleared under the same FDA submission (P150031); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026High impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION WHICH RESULTED IN A RETURN OF THEIR PARKINSON'S DISEASE SYMPTOMS BRADYKINESIA AND RIGIDITY. IT WAS DISCOVERED THAT THERE WERE HIGH IMPEDANCE READINGS ON THE NON-BOSTON SCIENTIFIC RIGHT-SIDED LEAD EXTENSION. THE SUBPECTORAL IMPLANTABLE PULSE GENERATOR (IPG) WAS PALPATED BY THE PHYSICIAN TO TROUBLESHOOT THE ISSUE HOWEVER, THIS DID NOT RESOLVE THE IMPEDANCE ISSUE. X-RAY IMAGING WAS TAKEN WHICH DID NOT REVEAL ANY APPARENT ANOMALIES. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH ONE OF THE BSC ADAPTERS WAS EXPLANTED AND REPLACED WHICH DID NOT RESOLVE THE IMPEDANCE ISSUE. THE PHYSICIAN THEN DECIDED TO REPLACE THE NON-BSC LEAD EXTENSION AFTER WHICH THE IMPEDANCE ISSUE WAS THEN RESOLVED AND THE PATIENT HAS FULLY RECOVERED POSTOPERATIVELY. THE EXPLANTED ADAPTER WILL NOT BE RETURNED DUE TO HOSPITAL POLICY.

  Patient problems: Insufficient Information

  MAUDE report 24384403 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150031. One submission often covers many models, so check the product and lot details in each record.

• Z-2340-2025 · Jul 8, 2025 · Open, Classified
  Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
• Z-2558-2025 · Jul 8, 2025 · Open, Classified
  Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
• Z-1890-2024 · Apr 18, 2024 · Open, Classified
  Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
• Z-2125-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the