Vercise™ DB-9218-55Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729905295), received between Jun 29, 2023 and Feb 16, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “High impedance” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2024High impedance; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem; High impedance; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION RESULTING IN A LACK OF TREMOR CONTROL. HIGH IMPEDANCE READINGS WERE OBSERVED, AND THE PHYSICIAN ASSESSED THAT A FALL THAT HAD OCCURRED SEVERAL MONTHS PRIOR WAS A CONTRIBUTING FACTOR. REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL, AND THE PATIENT UNDERWENT A PROCEDURE FOR SURGICAL TROUBLESHOOTING. DURING THE PROCEDURE, WHEN DISCONNECTING AND RECONNECTING THE M8 ADAPTER FROM THE IMPLANTABLE PULSE GENERATOR (IPG) DID NOT RESOLVE THE IMPEDANCE ISSUES, THE M8 ADAPTER WAS REPLACED. WHEN THE IMPEDANCE READINGS WERE ABNORMAL FOR WHAT WOULD BE EXPECTED WHEN CONNECTING TO A NON-BOSTON SCIENTIFIC LEAD, THE IPG WAS REPLACED. THE PATIENT DID WELL POSTOPERATIVELY, AND IMPEDANCE READINGS WERE WITHIN NORMAL LIMITS.

  Patient problems: Shaking/Tremors

  MAUDE report 18728072 ↗
• InjuryJun 29, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCES. REPROGRAMMING AROUND THE IMPEDANCES WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE DBS ADAPTOR WAS EXPLANTED. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSC.

  Patient problems: Pain

  MAUDE report 17227345 ↗

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