SenSight™ B31000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000426514), received between Jul 28, 2021 and Mar 6, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (5 reports).

20 other recalls cover devices cleared under the same FDA submission (H020007, P960009); 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE TAB ON THE BURR HOLE DEVICE SUPPORT CLIP THAT POPS UP TO LOCK THE DOOR CLOSED WAS NOT POPPING UP, LEAVING THE DOOR TO FREELY SWING OPEN AND CLOSE. WE OPENED A SECOND BURR HOLE TO RESOLVE IT, BUT THIS ONE HAD THE SAME PROBLEM. THE SCRUB THEN DECIDED TO PHYSICALLY BEND THE TAB INTO PLACE AND THE CLIP WORKED NORMALLY AFTER THIS. THE SECOND CLIP FROM WAS IMPLANTED. SURGERY DELAYED APPROXIMATELY 5 MINS. NO OTHER INTERVENTION TAKEN OR PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24534738 ↗
• MalfunctionJan 28, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE TAB ON THE BURR HOLE DEVICE SUPPORT CLIP THAT POPS UP TO LOCK THE DOOR CLOSED WAS NOT POPPING UP, LEAVING THE DOOR TO FREELY SWING OPEN AND CLOSE. WE OPENED A SECOND BURR HOLE TO RESOLVE IT, BUT THIS ONE HAD THE SAME PROBLEM. THE SCRUB THEN DECIDED TO PHYSICALLY BEND THE TAB INTO PLACE AND THE CLIP WORKED NORMALLY AFTER THIS. THE SECOND CLIP FROM WAS IMPLANTED. SURGERY DELAYED APPROXIMATELY 5 MINS. NO OTHER INTERVENTION TAKEN OR PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199740 ↗
• MalfunctionDec 3, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT IN BOTH CASES, THE SURGEON COULD NOT LOCK THE BURR HOLE CLIP. IT WAS UNKNOWN IF THERE WERE ANY CONTRIBUTING FACTORS. THE SURGEON TRIED TO CLEAN UP THE BURR HOLE FROM BONE SEGMENTS AND TRIED AGAIN BUT WITHOUT SUCCESS. THE CLIP WAS REPLACED BY ANOTHER ONE. THE ISSUE WAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE CASES OCCURRED IN THE SAME CASE, SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708091 ↗
• MalfunctionSep 18, 2025Unstable; Difficult to Open or Close; Unstable; Difficult to Open or Close

  IT WAS REPORTED THAT THE SUPPORT CLIP OF THE BURR HOLE DEVICE WOULD NOT CLIP IN OR SECURE THE LEAD PRIOR TO USE. THE SURGEON ATTEMPTED MULTIPLE TIMES TO SECURE THE CLIP WITHOUT SUCCESS. THE SUPPORT CLIP WAS REPLACED WITH A NEW ONE AND THE ISSUE RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086376 ↗
• MalfunctionSep 11, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE BURR HOLE COVER WAS NEVER IMPLANTED DUE TO NO BONE PURCHASE WITH THE SCREW. IT WAS STATED THAT THERE WAS NO PATIENT INVOLVED. IT WAS REPORTED THAT THE CAUSE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031816 ↗
• InjuryAug 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BURR HOLE CAP HAD FLOATED, AND IT COULD NOT BE MOUNTED PROPERLY. THE PERFORATION SITE WAS NOT FLAT, WHICH COULD HAVE CONTRIBUTED TO THE ISSUE. THE DEVICE WAS REMOVED SEVERAL TIMES AND WAS CHECKED FOR FOREIGN MATERIALS AND CLEANED. A SEPARATE KIT WAS OPENED AND ANOTHER CAP WAS USED. THE ISSUE WAS RESOLVED AT THE TIME OF THIS REPORT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22703519 ↗
• MalfunctionFeb 7, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING THE IMPLANT OF THE BURR HOLE DEVICE, THE SELF TAPPING SCREWS WERE TROUBLESOME AND WAS NOT TIGHTENING ON THE SCALP. THERE WERE NO CONTRIBUTING FACTORS. A DIFFERENT ORIENTATION ON THE SCALP WAS ATTEMPTED, BUT THE PROBLEM CONTINUED. A BACK UP BURR HOLE DEVICE WAS OPENED AND USED. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333009 ↗
• MalfunctionJul 28, 2021Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM A REP CLARIFIED THE FEET OF THE BURR HOLE DEVICE KEPT BENDING AND WOULD NOT SIT/CLICK IN; ONE FOOT WOULD NOT CLICK IN AFTER IT BENT. IT WORKED FINE WHEN THE HCP WENT IN PARALLEL/FLAT WITH NO ANGLE. IT WAS NOTED THAT ON THE SUCCESSFUL ATTEMPT THE HCP CLOSED THE BURR HOLE DEVICE AND PUT THE COVER ON AFTER THE FRAME WAS REMOVED. IT WAS ALSO NOTED THAT IT WAS MORE DIFFICULT TO PLACE THE COVER WHEN THE FRAME WAS IN PLACE; REMOVING THE FRAME HARDWARE OPENED UP THE SPACE TO WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12237589 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H020007, P960009. One submission often covers many models, so check the product and lot details in each record.

• Z-2240-2026 · May 13, 2026 · Open, Classified
  Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-2241-2026 · May 13, 2026 · Open, Classified
  Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-0206-2025 · Sep 24, 2024 · Open, Classified
  Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-0217-2024 · May 27, 2022 · Completed
  LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
• Z-1128-2022 · Mar 30, 2022 · Open, Classified
  Percept BrainSense Implantable Neurostimulator (INS), Model B35200
• Z-0418-2022 · Oct 19, 2021 · Open, Classified
  Model B35200 - Percept PC BrainSense Implantable Neurostimulator
• Z-0201-2022 · Sep 23, 2021 · Open, Classified
  Clinician Programmer Application (CPA) model A610 Clinician Software Application
• Z-1368-2021 · Mar 9, 2021 · Open, Classified
  A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.46
• Z-3069-2017 · Mar 17, 2017 · Terminated
  DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to
• Z-2645-2016 · Jun 23, 2016 · Terminated
  DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain
• Z-2602-2016 · Jun 10, 2016 · Terminated
  Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
• Z-1617-2015 · Apr 16, 2015 · Terminated
  Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
• Z-0279-2014 · Sep 30, 2013 · Terminated
  Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
• Z-1190-2013 · Feb 8, 2013 · Terminated
  Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system del

…and 5 more.