SureTek™ DB-4605-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729820819), received between May 16, 2023 and Apr 28, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 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.

Recalls naming this device

1. Jul 8, 2025Open, Classified

   Resistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of a Deep Brain Stimulation (DBS) system, which may lead to procedural delay, or lead-migration-which may require additional surgery.

   Z-2340-2025 · Root cause: Component change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THIS BURR HOLE COVER KIT WAS USED DURING A SURGICAL PROCEDURE. THE STERILE PACKAGING WAS OPENED AND THE CONTENTS OF THE KIT WERE POURED FROM THE PACKAGING ONTO THE STERILE FIELD. AFTER THE CONTENTS WERE POURED OUT, THE SURGICAL TECHNICIAN NOTED A HAIR ON THE OUTSIDE OF THE INNER PACKAGING OF THIS PRODUCT. THE DECISION WAS MADE TO PROCEED WITH THE USE OF THIS PRODUCT SINCE THE HAIR DID NOT CONTACT THE IMPLANTED PRODUCTS. THE PACKAGING WAS DISPOSED OF AND WAS NOT RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017909 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT'S INCISION AT THE BURR HOLE COVER (BHC) SITE DID NOT APPEAR TO BE HEALING APPROPRIATELY. SIGNS OF INFECTION WERE NOTED AT THE INCISION SITE, AND THE PATIENT EXHIBITED PURULENT DISCHARGE. THE PHYSICIANS PERFORMED A DEBRIDEMENT AND INITIATED ANTIBIOTIC THERAPY. THE PHYSICIAN ORDERED BLOODWORK TO CONFIRM WHETHER THE INFECTION WAS LIMITED TO THE EXTERNAL SITE; HOWEVER, RESULTS HAVE NOT BEEN REPORTED. AT THE MOST RECENT APPOINTMENT, THE PATIENT WAS NOTED TO BE DOING WELL WITH THERAPY. THE BHC WILL NOT BE RETURNED TO BOSTON SCIENTIFIC, AS IT REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: Bacterial Infection; Impaired Healing; Purulent Discharge

  MAUDE report 24599142 ↗
• MalfunctionFeb 20, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, A PORTION OF THE LOCKING CAP ON THE BURR HOLE COVER BROKE OFF WHEN THE PHYSICIAN ATTEMPTED TO CLOSE THE DOOR. THE BURR HOLE COVER WAS REPLACED, ALLOWING THE PROCEDURE TO BE COMPLETED SUCCESSFULLY AND THE PATIENT WAS DOING WELL POSTOPERATIVELY. IT WAS LATER CONFIRMED THAT THE LEAD STYLET HAD NOT BEEN REMOVED BEFORE THE SLIDER WAS LOCKED IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405063 ↗
• MalfunctionOct 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE WHEN ATTEMPTING TO CLOSE THE RETAINING CLIP ON BURR HOLE COVER, THE EXPECTED FIXATION CLICK DID NOT OCCUR. SEVERAL ATTEMPTS WERE MADE, BUT THE CLIP RETRACTED AND DID NOT SECURE. A REPLACEMENT BURR HOLE COVER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361170 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED IMPAIRED HEALING AND DISCOMFORT AROUND THE LEFT BURR-HOLE COVER OF THEIR DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PATIENT UNDERWENT A PROCEDURE WHERE THE WOUND WAS CLEANED OUT AND THE LEFT BURR-HOLE COVER REPLACED WITH A NON-BOSTON SCIENTIFIC DEVICE. THE PATIENT DID WELL POSTOPERATIVELY. PHYSICAL ANALYSIS OF THE DBS BURR-HOLE COVER WAS NOT PERFORMED AS IT WAS RETAINED BY THE FACILITY.

  Patient problems: Discomfort; Impaired Healing

  MAUDE report 16940845 ↗

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-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