SenSight™ B3301542Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00763000426439), received between Dec 13, 2021 and Sep 30, 2026 — classified as 3 deaths, 13 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (25 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 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Damaged Prior to Receipt by User

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950689 ↗
• MalfunctionJun 10, 2026Difficult to Remove; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED THAT BENT STYLET IN LEAD CAUSED DIFFICULTY REMOVING THE STYLET, CAUSED 2MM RETRACTION OF LEAD IN THE BRAIN. O-ARM SPIN FOLLOWING REMOVAL OF STYLET SHOWED THAT LEAD HAD RETRACTED IN THE BRAIN BY APPROX 2MM. SURGEON WAS ABLE TO MEASURE 2MM ON THE EXCESS LEAD THROUGH THE COVER AND THEN MANUALLY ADVANCE THE LEAD BY THAT AMOUNT. PLACEMENT WAS THEN VERIFIED BY ANOTHER O-ARM SPIN. LEAD REMAINS IMPLANTED AND ISSUE CONSIDERED RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25458759 ↗
• MalfunctionApr 20, 2026Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEAD WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24923887 ↗
• MalfunctionApr 8, 2026High impedance; Impedance Problem

  IT WAS REPORTED THAT MANUFACTURER REPRESENTATIVE (REP) HAD A CASE IN WHICH 4 LEADS WERE IMPLANTED. THERE WERE NO COMPLICATIONS WITH THE FIRST 3 LEADS. UPON TESTING IMPEDANCES WITH THE LAST LEAD, ALL IMPEDANCES WERE SHOWN RED. HEALTHCARE PROVIDER (HCP) TRIED MANY TROUBLESHOOTING METHODS INCLUDING WIPING DOWN THE LEAD, REPLACING THE LEAD TEST CABLE, ETC. SURGEON ULTIMATELY REQUESTED TO OPEN A NEW LEAD, WHICH WAS IMPLANTED WITH NO COMPLICATIONS. REP REPORTED THE ISSUE IS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24822718 ↗
• MalfunctionFeb 26, 2026Break

  ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING THAT ISSUE HAS BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462309 ↗
• MalfunctionFeb 26, 2026Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEAD APPEARS BENT, NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24454787 ↗
• MalfunctionFeb 5, 2026Migration or Expulsion of Device; Difficult to Remove; Malposition of Device

  IT WAS REPORTED THAT SURGEON PROVIDED FEEDBACK WHEN PULLING STYLET OUT FROM 1.5MM LEAD BEFORE FIXATING IT TO BHD AND SKULL THAT HE FELT THAT THE STYLET WAS DIFFICULT TO REMOVE FROM THE LEAD; THAT IT FELT TIGHT WITHIN THE LEAD AND CAUSED THE LEAD TO MOVE UPWARDS AND CAUSE ORIGINAL PLACEMENT CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268264 ↗
• MalfunctionDec 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE LEAD WAS BENT. POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE ISSUE WERE NOT REPORTED. THE PRODUCT WAS NOT IMPLANTED AND IS BEING RETURNED TO MANUFACTURER FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818929 ↗
• MalfunctionDec 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT BENT LEADS ARE BEING RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732665 ↗
• MalfunctionDec 5, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT BENT LEADS ARE BEING RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732664 ↗
• MalfunctionNov 24, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING THEY WERE PRESENT AT THE PROCEDURE. LEADS WERE OPENED AND HANDLED PROPERLY. THE PHYSICIAN CONFIRMED THAT LEADS WERE NOT STRAIGHT ON HIS BACK TABLE WHILE MEASURING THE LEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23634175 ↗
• MalfunctionNov 24, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED FROM REP INDICATING THEY WERE PRESENT AT THE PROCEDURE. LEADS WERE OPENED AND HANDLED PROPERLY. THE PHYSICIAN CONFIRMED THAT LEADS WERE NOT STRAIGHT ON HIS BACK TABLE WHILE MEASURING THE LEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23634168 ↗
• MalfunctionNov 19, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT BENT LEADS ARE BEING RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597414 ↗
• MalfunctionNov 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT HEALTHCARE PROVIDER (HCP) FOUND BENT LEADS PRIOR TO IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23587164 ↗
• MalfunctionNov 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) REPORTED FINDING BENT LEADS BEFORE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23577517 ↗
• MalfunctionNov 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) REPORTED FINDING BENT LEADS BEFORE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576886 ↗
• MalfunctionNov 12, 2025Material Deformation; Material Deformation

  ADDITIONAL INFORMATION RECEIVED FROM REP CLARIFYING THAT LEAD APPEARED BENT OUT OF THE BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536640 ↗
• MalfunctionOct 27, 2025Impedance Problem; Impedance Problem

  THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION, CONFIRMING THAT THE IMPEDANCE ISSUE IS NOW RESOLVED. THE HCP HAS NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399402 ↗
• MalfunctionOct 20, 2025Material Deformation; Material Deformation

  SEE H.11

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335592 ↗
• MalfunctionOct 20, 2025Material Deformation; Material Deformation

  SEE H.11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335589 ↗
• MalfunctionOct 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT LEADS WERE BENT PRE-OPERATIVELY. PRODUCT WAS REPLACED AND ISSUE WAS RESOLVED. LEADS ARE BEING RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316327 ↗
• MalfunctionOct 16, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT LEADS WERE BENT PRE-OPERATIVELY. PRODUCT WAS REPLACED AND ISSUE WAS RESOLVED. LEADS ARE BEING RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316259 ↗
• MalfunctionOct 15, 2025Material Deformation; Material Deformation

  SEE H.11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299183 ↗
• MalfunctionOct 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE LEADS WERE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23299086 ↗
• MalfunctionSep 11, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT DURING PHASE I IMPLANT, THE LEAD WAS CONNECTED TO THE TEST CABLE AND CONNECTIVITY AND IMPEDANCE TESTS FAILED. THE LEAD WAS RECONNECTED TO TEST CABLE, RAN IMPEDANCES ALONG WITH CONNECTIVITY TEST AND BOTH FAILED AGAIN. TROUBLESHOOTING INCLUDED REPLACING THE TEST CABLE AND REPEATED NOTED TESTS FOR THIS LEAD; BOTH TESTS FAILED. A SECOND LEAD WAS OPENED AND PLACED AND THAT LEAD ALSO FAILED BOTH THE CONNECTIVITY AND IMPEDANCE TEST USING BOTH OF THE OPENED TEST CABLES PREVIOUSLY NOTED. A THIRD LEAD WAS OPENED AND PLACED AND THIS PASSED BOTH TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23030489 ↗

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-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-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-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.