NA DB-4254Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729896104), received between Feb 11, 2020 and Jun 2, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2026Use of Device Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EXCESSIVE BLEEDING DURING THEIR SECOND STAGE IMPLANT PROCEDURE WHEN THE PHYSICIAN WAS USING THE TUNNELING TOOL. THE PHYSICIAN BELIEVED THAT THE TUNNELING TOOL WAS TOO SHARP AND MALLEABLE RESULTING IN SOME ADDITIONAL BLEEDING ALONG THE TUNNELING TRACK. PRESSURE WAS HELD OVER THE SITE OF THE BLEEDING FOR TEN MINUTES AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS. THE PATIENT HAS FULLY RECOVERED POSTOPERATIVELY. THE TUNNELING TOOL WILL NOT BE RETURNED AS IT WAS RETAINED BY THE CUSTOMER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25368555 ↗
• InjuryMay 14, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING DEEP BRAIN STIMULATION (DBS) STAGE 2, THE STRAW FROM THE TUNNELING TOOL BECAME CAUGHT IN TISSUE DURING THE TUNNELING PROCESS AND LED TO BLEEDING. DUE TO DEFORMATION AND LOSS OF FUNCTION OF THE OUTER SHEATH, THE TUNNELING PROCESS COULD NOT BE COMPLETED WITH THE INITIAL PRODUCT. DURING THE EVENT, THE SHEATH CATCHING WITHIN THE TISSUE WAS ASSOCIATED WITH INCREASED RESISTANCE AND RESULTED IN NOTABLE BLEEDING AT THE TUNNELING SITE. HEMOSTASIS WAS ACHIEVED INTRAOPERATIVELY. THE TUNNELING DEVICE WAS REPLACED WITH A NEW UNIT, WHICH FUNCTIONED AS INTENDED AND ALLOWED SUCCESSFUL COMPLETION OF THE PROCEDURE. THE PATIENT TOLERATED THE REMAINDER OF THE PROCEDURE WELL AND IS EXPECTED TO RECOVER WITHOUT COMPLICATIONS. THE DEVICE WAS DISCARDED AT THE FACILITY AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25167327 ↗
• InjuryJan 22, 2026Break

  IT WAS REPORTED THAT DURING THE DEEP BRAIN STIMULATION (DBS) STAGE 2 IMPLANT PROCEDURE, AFTER MAKING THE USUAL HEAD AND CHEST INCISIONS, TUNNELING WAS ATTEMPTED WITH THE BOSTON SCIENTIFIC TUNNELING TOOL. AFTER REPEATED ATTEMPTS AT SHAPING THE TOOL TO COMPLETE THE PASS, THE PHYSICIAN ATTEMPTED TO MODIFY THE TIP OF THE TUNNELING TOOL. DURING THE SUBSEQUENT TUNNELING ATTEMPT, THE TIP WAS FOUND TO HAVE DETACHED INSIDE THE PATIENT. A SMALL MID PATH INCISION WAS MADE TO SUCCESSFULLY REMOVE THE TUNNELER TIP. A NON BOSTON SCIENTIFIC TUNNELING TOOL WAS THEN USED TO COMPLETE THE SURGERY. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141884 ↗
• InjuryJan 15, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE DEEP BRAIN STIMULATION (DBS) PROCEDURE THE TUNNELING TOOL STRAW BECAME COMPLETELY SPLIT WHEN REMOVING IT DOWN THROUGH THE CHEST INCISION. ULTIMATELY, THE PHYSICIAN MADE AN ADDITIONAL INCISION AT THE LATERAL ASPECT OF THE NECK IN ORDER TO CUT OUT AND RETRIEVE THE REST OF THE STRAW FROM THE PATIENTS NECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24090268 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM, THE PHYSICIAN ENCOUNTERED AN ISSUE WHILE TUNNELING THE LEAD. THE TUNNELING TOOL INADVERTENTLY EXITED THE SKIN AND THEN RE-ENTERED BEFORE REACHING THE POCKET SITE IN THE CHEST. DUE TO THE BREACH OF THE STERILE FIELD AND POTENTIAL CONTAMINATION, THE PHYSICIAN ELECTED TO REPLACE BOTH LEAD EXTENSIONS AND SUCCESSFULLY RE-TUNNELED THE NEW EXTENSIONS UNDER STERILE CONDITIONS. THE PATIENT SUBSEQUENTLY EXPERIENCED BLEEDING, PAIN, DISCOMFORT, SWELLING, AND REDNESS ALONG THE TUNNELING PATH. THERE WERE NO OTHER REPORTED COMPLICATIONS POSTOPERATIVELY. THE PHYSICIAN ATTRIBUTED THE TUNNELING COMPLICATION TO THE SHARPNESS AND FLIMSINESS OF THE TUNNELING TOOL.

  Patient problems: Discomfort; Erythema; Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 23348728 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE COMPLETION OF A SCHEDULED DEEP BRAIN STIMULATION (DBS) PROCEDURE, REMOVAL OF THE SURGICAL DRAPES REVEALED A SMALL SECTION OF THE LEAD EXTENSION PROTRUDING THROUGH THE PATIENTS SKIN. UPON ASSESSMENT, THE PHYSICIAN DETERMINED THAT THE TUNNELING TOOL HAD EXITED AND RE-ENTERED THE SKIN DURING THE PLACEMENT OF THE EXTENSIONS, RESULTING IN THE EXPOSURE. AN IMMEDIATE CORRECTIVE PROCEDURE WAS PERFORMED. THE PHYSICIAN EXCISED AND REMOVED THE COMPROMISED LEAD EXTENSIONS, SUTURED THE PUNCTURE SITES, AND RE-TUNNELED USING A NON-BOSTON SCIENTIFIC CODMAN TOOL. NEW LEAD EXTENSIONS WERE IMPLANTED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATION. ANALYSIS OF THE DEVICES WAS NOT PERFORMED AS THEY HAD BEEN DISCARDED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

  Patient problems: Erosion; Needle Stick/Puncture; Perforation

  MAUDE report 22503279 ↗
• InjuryMar 20, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE THE PHYSICIAN EXPERIENCED DIFFICULTY IN USING THE TUNNELLING TOOL AS THE PATIENT HAD TOUGH, LEATHERY SKIN AND SCALP WHEREIN CAUSING THE PATIENT TO BLEED MORE THAN THE NORMAL. THE PHYSICIAN APPLIED PRESSURE, GAUZE AND SUCTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21655716 ↗
• InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE PUNCTURE SITE CAUSED BY THE TUNNELING TOOL, WHICH WAS PREVIOUSLY REPORTED UNDER MFR# 3006630150-2024-06706.

  Patient problems: Unspecified Infection

  MAUDE report 21541734 ↗
• InjuryOct 4, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PHYSICIAN EXPERIENCED DIFFICULTY USING THE TUNNELING TOOL DURING AN IMPLANT PROCEDURE. THE TIP OF THE TUNNELING TOOL PUNCTURED THROUGH THE SKIN OF THE PATIENT'S NECK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PUNCTURE WAS CLOSED WITH STAPLES.

  Patient problems: Perforation

  MAUDE report 20377538 ↗
• InjuryMay 22, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOW BLOOD PRESSURE DURING THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) PROCEDURE. X-RAY IMAGES TAKEN REVEALED A PNEUMOTHORAX AND HEMOTHORAX APPROXIMATELY ONE LITER IN VOLUME IN THE RIGHT LUNG. THE PHYSICIANS ASSESSMENT NOTED THAT HE EXPERIENCED DIFFICULTIES TUNNELING SUBCUTANEOUSLY CROSSING OF THE NECK AND POSSIBLY DAMAGED THE BLOOD VESSELS AND PARIETAL PLEURA. THE PATIENT UNDERWENT A BLOOD TRANSFUSION, A CHEST TUBE WAS PLACED, WAS STABILIZED AND PLACED IN INTENSIVE CARE UNIT (ICU). IT WAS NOTED THAT THE PATIENT IS THIN, AND THE PHYSICIAN HAS ONLY USED THE BOSTON SCIENTIFIC TUNNELING TOOL SEVEN PRIOR TIMES, HOWEVER, HAS EXPERIENCE WITH COMPETITORS SIMILAR TOOLS. PHYSICAL ANALYSIS OF THE DBS TUNNELER WAS NOT PERFORMED AS IT WAS DISPOSED BY THE FACILITY. THE DRAIN WAS REMOVED SEVERAL DAYS LATER, AND THE PATIENT IS DOING WELL.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hemothorax; Low Blood Pressure/ Hypotension; Pneumothorax

  MAUDE report 19378197 ↗
• InjuryMay 16, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE WHILE TUNNELING THE LEAD EXTENSION WITH THE TUNNELING TOOL THE SURGEON PERFORATED THE SKIN. THE SKIN PUNCTURE WAS SUTURED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE TUNNELING TOOL WAS DISCARDED BY THE FACILITY AND NOT RETURNED FOR ANALYSIS.

  Patient problems: Perforation

  MAUDE report 19337568 ↗
• InjuryApr 18, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT'S SKIN WAS PUNCTURED IN SEVERAL PLACES AT THE NECK AREA WHILE USING THE TUNNELING TOOL DURING AN IMPLANT PROCEDURE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE SKIN PUNCTURES WERE SUTURED, AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC TUNNELING TOOL. THE PATIENT DID WELL POSTOPERATIVELY. THE PHYSICIAN STATED THAT THE DEVICE WAS DIFFICULT TO USE, HOWEVER IT WAS DISCARDED BY THE FACILITY AND NOT RETURNED FOR ANALYSIS.

  Patient problems: Perforation

  MAUDE report 16762959 ↗
• InjuryFeb 11, 2020Use of Device Problem; Human-Device Interface Problem; Use of Device Problem; Human-Device Interface Problem

  A REPORT WAS RECEIVED THAT DURING THE DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE THE PATIENT EXPERIENCED A STROKE AS A RESULT OF A CAROTID DISSECTION IN THE RIGHT HEMISPHERE OF THE BRAIN. THE PHYSICIAN BELIEVES THAT THE CAROTID ARTERY WAS NICKED WHILE TUNNELING DURING THE PROCEDURE. THE LEFT SIDE OF THE PATIENT EXHIBITED LIMITED MOBILITY POST-OPERATIVELY. THE DBS STIMULATION WAS PROGRAMMED TO PROVIDE THE PATIENT WITH TREMOR RELIEF ON THE RIGHT SIDE AND TO GET THE LEFT SIDE USED TO THE STIMULATION EFFECTS. THE PATIENT WILL CONTINUE WITH REHABILITATION FOR THE LEFT SIDE TO ASSIST IN REGAINING MOBILITY. THE TUNNELER WAS DISCARDED BY THE FACILITY.

  Patient problems: Stroke/CVA

  MAUDE report 9696240 ↗

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