SureTek™ DB-4600-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 08714729820802), received between Jan 3, 2018 and Sep 30, 2026 — classified as 115 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (28 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 138 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erosion; Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 50941500 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced erosion at the burr hole cover, of the Deep Brain Stimulation (DBS) system, left scalp site completely exposing the burr hole cover. The patient underwent a procedure in which all the devices were explanted, to reduce the risk of infection, with a flap revision closure of the site. The physician could not confirm whether the device was the cause of the erosion or whether the patient picked at the site and caused the wound to open. Cultures were taken during the procedure; however, the results of the culture and whether an infection was confirmed were not provided due to facility policy. The patient was prescribed antibiotics and doing well post operatively, with tremors at baseline. The devices will not be returned as they were disposed of by the facility.

  Patient problems: Erosion

  MAUDE report 50288809 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erosion; Head Injury; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50255877 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during the deep brain stimulation (DBS) implant procedure after the Burr Hole Cover was implanted the patient became unresponsive and experienced a seizure. The Burr Hole Cover was removed, and the patient was doing well postoperatively. The physician assessed that opening up the hole in the skull to place the BHC caused the patient to lose some of his faculties, not the device itself. The Burr Hole Cover was retained by the medical facility and was not returned. The patient is scheduled to complete the full implant procedure in the very near future.

  Patient problems: Convulsion/Seizure; Decreased Level of Consciousness

  MAUDE report 50246170 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during the deep brain stimulation (DBS) implant procedure while inserting the right lead insertion tube the patient experienced slurred speech. The physician decided not to proceed with the right lead implant and the procedure was aborted. The patient was doing well postoperatively, however continues to present with slurred speech. The physician assessed that the event was most likely related to the procedure and not the device. Once the patients slurred speech has resolved they will reschedule a date in the future to complete the implant procedure.

  Patient problems: Speech Disorder

  MAUDE report 50130540 ↗
• InjuryJul 28, 2026Use of Device Problem

  It was reported that during a Deep Brain Stimulation (DBS) lead implantation procedure, the head of a screw from the burr hole kit sheared off while being tightened. The screw fragment remained retained in the bone. No patient injury or adverse effects were reported. Attempts were made to retrieve the retained screw fragment using a clamp; however, successful removal would have required drilling additional bone surrounding the screw, resulting in a larger bony defect. To avoid further complications, the decision was made to leave the screw fragment in place. It could not be determined which of the implanted burr hole cover kits was associated with the sheared screw. As part of the intervention, a new screw was used to complete the procedure and secure the implant as intended. Postoperatively, no patient complications related to the event were reported.

  Patient problems: Foreign Body In Patient

  MAUDE report 50063888 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced erosion, an open wound on the scalp, above the burr hole cover and underwent a full system explant. An infection was suspected, for which cultures were taken and confirmed bacterial infections of Klebsiella oxytoca, Raoultella ornithinolytica, Stenotrophomonas maltophilia and Haemophilus parainfluenzae; the patient was prescribed antibiotics and is doing well post operatively. No additional symptoms were reported related to the erosion or the infection. The devices were not returned to the manufacturer for analysis as they were all discarded by the facility.

  Patient problems: Bacterial Infection; Erosion; Wound Dehiscence

  MAUDE report 25803849 ↗
• InjuryJun 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT BOTH OF THE BURR HOLE AND BILATERAL LEAD SITES, OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM, ON THE SKULL. THE INFECTION DEVELOPED DUE TO THE INCISION SITES OPENING UP BECAUSE OF THE DEVICES RUBBING ON THE SKIN CAUSING SKIN EROSION. THE PATIENT SYMPTOMS INCLUDED PAIN, SWELLING AND REDNESS AT THE SITE. THE PATIENT WAS PRESCRIBED MEDICATION, PENDING NEXT COURSE OF ACTION. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Erosion; Erythema; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 25586250 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT HAS A CONGEALING WOUND OVER LEFT BURR HOLE COVER, CAUSING AN EROSION AT THE LEAD SITE. TO ADDRESS THIS, THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE IN THE PLASTIC SURGEON CLOSE THE INCISION. POST OPERATIVELY THE PATIENT DID GREAT AND THE WOUND LOOKS GREAT.

  Patient problems: Erosion

  MAUDE report 25436536 ↗
• InjuryJun 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A SUSPECTED INFECTION AT THE RIGHT HEAD OVER THE BURR HOLE COVER SITE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM. IT WAS CONFIRMED THAT THE PATIENT PICKED AT THE INCISION SITE CAUSING THE DEVICE TO BECOME EXPOSED. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE BURR HOLE COVER CAP WAS REPLACEMENT PROCEDURE, THE WOUND WAS CLOSED AND THE PATIENT IS DOING WELL POST OPERATIVELY. THE INFECTION WAS NOT CONFIRMED, AND THE CAP WILL NOT BE RETURNED IT WAS DISPOSED OF BY THE FACILITY. IT IS UNCLEAR AS TO WHICH OF THE TWO BURR HOLE COVER CAPS WAS REPLACED.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 25418324 ↗
• MalfunctionApr 28, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THIS BURR HOLE COVER KIT PACKAGING WAS NOTED NOT TO BE SEALED. BECAUSE THE STERILITY OF THE PRODUCT WAS IN QUESTION, THIS PRODUCT WAS NOT USED AND WAS PLANNED TO BE RETURNED FOR ANALYSIS. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019529 ↗
• MalfunctionApr 28, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO THE USE OF THIS BURR HOLE COVER KIT DURING A PROCEDURE, THE SCRUB TECH REPORTED THE PRODUCT HAD A HAIR ON IT. THE PRODUCT HAD ALREADY BEEN ATTACHED TO A SYRINGE AND THERE WAS SOME SUSPICION THE HAIR WAS INTRODUCED DURING ATTACHMENT OF THE SYRINGE. THIS PRODUCT WAS NOT USED, AND ANOTHER BURR HOLE COVER KIT WAS SUCCESSFULLY USED. THE ATTEMPTED BURR HOLE COVER KIT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25017775 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION AT THE BURR HOLE COVER SITE SHOWING SIGNS OF REDNESS AROUND THE WOUND. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE WOUND WAS CLEANED AND ANTIBIOTICS WERE ADMINISTERED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

  Patient problems: Erosion; Erythema

  MAUDE report 24619683 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED CARDIAC ARREST DURING AN IMPLANT PROCEDURE AFTER THE BURR HOLE COVER WAS IMPLANTED. RESUSCITATION WAS PERFORMED SUCCESSFULLY, THE INCISION WOUND WAS CLOSED AND THE DBS PROCEDURE WAS DISCONTINUED. THE PHYSICIAN ASSESSED THAT THE EVENT WAS LIKELY PATIENT-CAUSED AND NOT DEVICE RELATED. THERE WERE NO FURTHER REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY AND THE DBS IMPLANTATION PROCEDURE IS PLANNED TO BE PERFORMED AGAIN IN THE FUTURE.

  Patient problems: Cardiac Arrest

  MAUDE report 24401746 ↗
• MalfunctionJan 12, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION (DBS) IMPLANTATION SURGERY, THE LEAD COULD NOT BE SECURED TO THE BASE USING THE BURR HOLE COVER'S (BHC) RETAINING CLIP. UPON CLOSER INSPECTION, IT APPEARED THAT THE RETAINING CLIP WAS BENT. THE ATTENDING PHYSICIAN MANUALLY ADJUSTED THE CLIP SLIGHTLY, ENABLING ATTACHMENT TO THE BASE AND USED IT AS IS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE BHC WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032927 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SUSPECTED CEREBROSPINAL FLUID (CSF) LOSS AND UNDERWENT A REVISION OF THE BURR HOLE COVER IN WHICH THE BURR HOLE COVER CLIP AND CAP WERE REMOVED. THE PHYSICIAN DECIDED TO FIXATE THE LEAD USING BONE CEMENT TO PREVENT CSF LOSS. NO DEVICE WILL BE RETURNED. IT WAS ADDITIONALLY REPORTED THAT IT IS UNCLEAR AS TO WHICH OF THE TWO IMPLANTED LEADS WAS INVOLVED, AND THAT THE REMOVED DEVICE WAS DISPOSED OF BY THE FACILITY.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 23970841 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AT THE INCISION SITES ON THE HEAD WHERE THE BURR HOLE COVERS WERE IMPLANTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

  Patient problems: Bacterial Infection; Purulent Discharge; Unspecified Infection

  MAUDE report 23660816 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENTS' SKIN WAS THIN AND CAUSED IMPAIRED HEALING CAUSING EROSION OF THE BURR HOLE COVER OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM TO BE EXPOSED. THE PHYSICIAN DECIDED TO EXPLANT THE ENTIRE SYSTEM. IT IS UNCLEAR AS TO WHICH OF THE TWO BURR HOLE COVERS WAS EXPOSED. THE PATIENT IS DOING WELL POST OPERATIVELY, NO DEVICES WILL BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY.

  Patient problems: Erosion; Impaired Healing

  MAUDE report 23624913 ↗
• MalfunctionNov 19, 2025Use of Device Problem; Migration; Use of Device Problem; Migration

  IT WAS REPORTED THAT DURING THE DEEP BRAIN STIMULATION (DBS) LEAD IMPLANT PROCEDURE THE RETAINING CLIP ON THE BURR HOLE COVER WAS NOT SECURE INSIDE THE BASE RING DURING CLOSING, AND THE LEAD MIGRATED. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM ON THE SAME DAY WHERE THE PHYSICIAN ATTEMPTED TO ADVANCE THE LEAD BUT IT WOULD NOT FOLLOW THE SAME FRESH TRACK. THE SITE WAS SUTURED AND CLOSED. THE PATIENT EXPERIENCED PNEUMOCEPHALUS POST OPERATIVELY. THE PATIENT LATER UNDERWENT A REVISION PROCEDURE WHERE THE BURR HOLE COVER AND LEAD WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE HOSPITAL AND WERE NOT RETURNED.

  Patient problems: Pneumocephalus

  MAUDE report 23600884 ↗
• InjuryOct 22, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE DURING FIXATION, THE RETAINING CLIP ON THE BURR HOLE COVER (BHC) FRACTURED INTO TWO PIECES PREVENTING PROPER USE. THE BROKEN BHC WAS REPLACED WITH A NEW ONE AND THE PROCEDURE WAS COMPLETELY SUCCESSFULLY. BOSTON SCIENTIFIC WAS UNABLE TO CONFIRM IF THE TWO BROKEN PIECES OF THE BHC WERE RETRIEVED FROM PATIENTS BODY. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE BROKEN RETAINING CLIP PIECES WERE REMOVE FROM THE PATIENTS BODY BEFORE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23361169 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, THE PHYSICIAN BEGAN MAKING THE INCISIONS FOR THE BURR HOLE COVERS (BHC) WHEN THE PATIENT'S VITAL SIGNS BEGAN TO DROP. THE STEREOTACTIC FRAME HAD TO BE QUICKLY REMOVED SO THAT THE ANESTHESIOLOGIST COULD INTERVENE. THE ANESTHESIOLOGIST SUCCESSFULLY STABILIZED THE PATIENT'S VITALS, BUT THE PHYSICIAN DECIDED TO ABORT THE CASE AND RESCHEDULE FOR ANOTHER DAY. THE PATIENT HAS FULLY RECOVERED AND HAS BEEN RESCHEDULED FOR SURGERY. THE BHCS WERE DISPOSED OF BY THE SURGEON FOLLOWING THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 23023373 ↗
• InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE, AFTER THE BURR HOLE COVERS WERE PLACED, THE PHYSICIAN BEGAN CAUTERIZING THE DURA PRIOR TO INSERTING THE CANNULA AS PART OF THE PROCEDURE. AT THAT POINT, THE PATIENT WENT INTO ATRIAL FIBRILLATION (AFIB), AND THE CASE WAS ABORTED. THE BURR HOLE CAPS WERE LEFT IN PLACE IN CASE THE LEADS ARE RE-IMPLANTED AT A LATER TIME. THE CAUSE OF THE INCIDENT REMAINS UNKNOWN; A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND APPEARED NORMAL. THE PATIENT HAS SINCE RECOVERED AND WAS REFERRED TO CARDIOLOGY.

  Patient problems: Atrial Fibrillation

  MAUDE report 23023322 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A BURR HOLE COVER AND LEAD EXPLANT DUE TO INFECTION AT THE BURR HOLE COVER SITE. THE PATIENT PRESENTED WITH AN OPEN WOUND, AND THE PHYSICIAN SUSPECTED THAT THE PATIENT MAY HAVE BEEN SCRATCHING THE SITE. THE PATIENT WAS PLACED ON ANTIBIOTICS. ALTHOUGH CULTURES WERE OBTAINED, THE RESULTS WERE NOT DISCLOSED. THE PATIENT WAS REPORTED TO BE DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BOSTON SCIENTIFIC, AS THEY WERE RETAINED BY THE FACILITY.

  Patient problems: Bacterial Infection; Impaired Healing; Itching Sensation; Perforation

  MAUDE report 22865907 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EXTRUSION AT THE SITE OF THE BURR HOLE COVER WHEREIN THE DEVICE WAS COMING THROUGH THE SKIN AND CAUSING THE PATIENT DISCOMFORT. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE DEVICE MODELS, SERIAL NUMBERS AND IMPLANT DATES. ADDITIONAL INFORMATION WAS RECEIVED PROVIDING THE MODEL AND LOT NUMBER OF THE ADDITIONAL BURR HOLE COVER THAT WAS EXPLANTED.

  Patient problems: Discomfort; Erosion

  MAUDE report 22765420 ↗
• InjuryJul 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE RIGHT-SIDED LEAD AND BURR HOLE COVER (BHC) DUE TO INFECTION. THE PATIENT EXPERIENCED FLUID DISCHARGE AT THE AFFECTED SITE. ANTIBIOTIC THERAPY WAS INITIATED TO MANAGE THE INFECTION, AND CULTURES WERE OBTAINED; HOWEVER, THE RESULTS WERE NOT DISCLOSED. THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE. ALL EXPLANTED COMPONENTS WERE DISCARDED AND WILL NOT RETURN FOR ANALYSIS.

  Patient problems: Bacterial Infection; Fluid Discharge

  MAUDE report 22405252 ↗

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