Vercise Genus™ DB-1432Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729985037), received between Sep 6, 2022 and May 29, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Battery Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2026Battery Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT THE REPLACEMENT OF THE IMPLANTABLE PULSE GENERATOR (IPG) DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334433 ↗
• InjuryMay 8, 2026Battery Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT RECEIVED THE END OF BATTERY LIFE (EBL) MESSAGE OF THE IMPLANTABLE PULSE GENERATOR (IPG) SHORTLY AFTER IMPLANTATION. THE DEVICE REMAINS IMPLANTED. A REPLACEMENT PROCEDURE IS ANTICIPATED IN THE FUTURE; HOWEVER, NO SPECIFIC DATE HAS BEEN ESTABLISHED AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Dyskinesia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129048 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED IMPAIRED HEALING AT THE INCISION SITE AND IT WAS DISCOVERED BY THE PHYSICIAN THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD ERODED THROUGH THE SKIN. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE POSTOPERATIVELY. THE EXPLANTED IPG WILL NOT BE RETURNED AS IT WAS RETAINED BY THE MEDICAL FACILITY.

  Patient problems: Impaired Healing; Pocket Erosion

  MAUDE report 24274099 ↗
• InjuryDec 9, 2025Migration; Migration

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE TO SECURE THE IMPLANTABLE PULSE GENERATOR (IPG) WITHIN THE POCKET. THE IPG HAD NOT BEEN SUTURED DURING THE INITIAL IMPLANT PROCEDURE, AND THE PATIENT REPORTED FEELING IT MOVING WITHIN THE SUBCLAVICULAR POCKET. SUTURES WERE PLACED THROUGH THE IPG EYELETS TO SECURE THE DEVICE TO TISSUE. THE PATIENT IS STABLE POSTOPERATIVELY. THE DEVICE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC AS IT REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23763999 ↗
• InjuryJul 8, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440288 ↗
• MalfunctionMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE ANALYSIS PERFORMED ON THE RETURNED IMPLANTABLE PULSE GENERATOR (IPG) REVEALED COMMUNICATION COULD NOT BE ESTABLISHED WITH A KNOWN GOOD REMOTE CONTROL OR CLINICIAN PROGRAMMER. INVESTIGATION OF THE INTERNAL ELECTRICAL MEASUREMENTS REVEALED EXCESSIVE SLEEP CURRENT AND LOW RESISTANCE OF A NODE WHERE HIGH RESISTANCE WAS EXPECTED, WHICH CONFIRMS THAT THE APPLICATION-SPECIFIC INTEGRATED CIRCUIT (ASIC) CHIP IS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612573 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED CONFUSION AND DISORIENTATION EIGHT DAY POST-IMPLANT PROCEDURE THAT WAS MODERATE IN SEVERITY. THE DEEP BRAIN STIMULATION PATIENT WAS ADMITTED TO THE HOSPITAL AND ADMINISTERED MEDICATION. THE REPORTED EVENT HAS SINCE RESOLVED. THE PHYSICIAN ASSESSED THE EVENT AS HAVING HAD A PROBABLE RELATIONSHIP TO THE PROCEDURE AND NOT DEVICE OR STIMULATION RELATED.

  Patient problems: Confusion/ Disorientation

  MAUDE report 15366769 ↗

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-2558-2025 · Jul 8, 2025 · Open, Classified
  Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
• 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-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