SenSight™ B31040Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000426552), received between Oct 2, 2023 and Sep 22, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High impedance” (7 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.

• MalfunctionSep 22, 2026Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854747 ↗
• MalfunctionNov 3, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING AN IMPEDANCE CHECK, POLES 0 AND 1B SHOWED HIGH VALUES GREATER THAN 20 KO, INDICATING A MALFUNCTION OF THE TEST CABLE. AN IMPEDANCE CHECK WAS PERFORMED, AND A SECOND UNIT OF THE SENSIGHT TEST CABLE WAS USED FOR COMPARISON, WHICH OPERATED NORMALLY AND CONFIRMED THE DEFECT IN THE FIRST UNIT. THE PHYSICIAN WAS GIVEN INSTRUCTIONS ON THE PROPER HANDLING OF THE TEST CABLE AND CLEANING OF THE ELECTRODE. ADDITIONAL TESTS WERE SUGGESTED TO VALIDATE FUNCTIONALITY, BUT THE ISSUE PERSISTED. THE USE OF A SECOND SENSIGHT TEST CABLE RESOLVED THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451536 ↗
• MalfunctionJul 28, 2025High impedance; Connection Problem; High impedance; Connection Problem

  IT WAS REPORTED THAT THE TEST CABLE CONNECTION FAILURE WITH THE ELECTRODE. THERE WAS NO EXTERNAL INTERFERENCE OBSERVED THAT COULD HAVE CAUSED THE ISSUE. TRIED TO MAKE THE CONNECTION SEVERAL TIMES, BUT IMPEDANCE REMAINED HIGH. OPENED ANOTHER CABLE TEST AND IT WORKED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629363 ↗
• MalfunctionJun 30, 2025High impedance; High impedance

  IT WAS REPORTED THAT DURING DEEP BRAIN STIMULATION SURGERY, THE LEAD TEST CABLE EXHIBITED HIGH IMPEDANCE. NO SURGICAL INTERVENTION OCCURRED AND THE ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358369 ↗
• MalfunctionJun 16, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE MEASURING CABLE SHOWED IMPEDANCES WERE >40,000 OHM ON CONTACTS 2C AND 3. THERE WERE NO KNOWN CONTRIBUTING FACTORS. THE MEASURING CABLE WAS RECONNECTED, ROTATED, AND THE ELECTRODE WAS CLEANED SEVERAL TIMES BUT THE ISSUE PERSISTED. THE MEASURING CABLE WAS REPLACED WITH A NEW ONE, AFTER WHICH NO FURTHER ABNORMALITIES WERE FOUND, IMPEDANCES WITHIN THE NORMAL RANGE. THE ISSUE WAS RESOLVED. (B)(6) 2025 E1 (FOR, REP): NO NEW INFORMATION. (B)(6) 2025 E2 (REP, FOR) NO NEW INFORMATION (B)(6) 2025 AN_RP (FOR, REP); NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213904 ↗
• MalfunctionDec 12, 2023High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE CAUSE OF THE HIGH IMPEDANCE WAS DUE TO THE TESTING CABLE WHICH OCCURRED ON NOVEMBER 30TH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18315412 ↗
• MalfunctionNov 20, 2023High impedance; High impedance

  IT WAS REPORTED THAT TESTED THE LEAD INTRA-OP THE IMPEDANCES WERE ALL HIGH. THE LEAD CABLED WAS SWAPPED AND THE IMPEDANCES RESOLVED. IT WAS TRIED 3 TIMES BEFORE SWITCHING THE CABLE THERE WAS NO CHANGE. ACTIONS TAKEN WERE SWAPPED THE CABLE AFTER RECONNECTING 3 TIMES, PUSHING THE STYLET IN, AND RESISTING THE CABLE WITH THE LEAD TEST CABLE JAWS CLOSED. THE ISSUE WAS RESOLVED. NO SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE CAUSE WAS NOT DETERMINED. THE STYLET WAS PUSHED DOWN, TWISTED THE LOCKING CABLE TO GET RID OF ANY PASSIBLE FILM, THE LEAD WAS WHIPPED MULTIPLE TIMES AND RE-INSERTED WITH NO CHANGE. A NEW TEST CABLE WAS OPENED AND THE ISSUE WAS RESOLVED. THIS WAS INFORMATION CONFIRMED WITH THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169470 ↗
• MalfunctionOct 2, 2023High impedance; High impedance

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE CAUSE OF THE IMPEDANCE ISSUE WASN¿T DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851731 ↗

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.