SureTekRecalls & reported problems across all models

We found 2 models of SureTek by Boston Scientific Neuromodulation Corporation in the FDA's device registry (GUDID). Together they are named in 143 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2018 and Sep 30, 2026 — classified as 117 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (30 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

SureTek recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 2 of these models · Recall details · FDA record ↗

Most reported SureTek problems

SureTek models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SureTek™ DB-4600-C

  Stimulator, electrical, implanted, for essential tremor
  1 recall138 reports
• SureTek™ DB-4605-C

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
  1 recall5 reports

Recent SureTek adverse event reports

The 15 most recent reports across all models, 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 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 ↗
• 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 ↗
• 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 ↗

Other Boston Scientific Neuromodulation Corporation products

• Precision Spectra3 models · 11,348 reports
• Spectra WaveWriter4 models · 7,251 reports
• Precision17 models · 6,725 reports
• WaveWriter Alpha3 models · 4,356 reports · 1 recall
• Precision Montage MRI2 models · 4,332 reports
• Linear ST5 models · 4,068 reports
• Infinion CX2 models · 2,139 reports · 1 recall
• Superion5 models · 1,488 reports · 2 recalls