SenSightRecalls & reported problems across all models
Medtronic, Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one SenSight model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 510
- Deaths reported
- 12
- Injuries reported
- 131
- Recalls
- 2
We found 18 models of SenSight by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 510 adverse event reports in the FDA's MAUDE database, received between Jun 8, 2021 and Sep 30, 2026 — classified as 12 deaths, 131 injuries, 367 malfunctions.
The most frequently reported specific device problem is “High impedance” (144 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 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
Reports received per month, all models
SenSight 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.
- Mar 17, 2023Open, Classified
Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.
Z-1408-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Jan 20, 2023Open, Classified
Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label.
Z-0121-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported SenSight problems
Device problems
- High impedance144
- Adverse Event Without Identified Device or Use Problem64
- Material Twisted/Bent59
- Insufficient Device Problem Information55
- Break53
- Material Deformation50
- Impedance Problem34
- Device Markings/Labelling Problem21
Patient problems
- No Clinical Signs, Symptoms or Conditions440
- Intracranial Hemorrhage31
- Stroke/CVA12
- Confusion/ Disorientation9
- Convulsion/Seizure9
- Insufficient Information9
- Hemorrhage/Blood Loss/Bleeding8
- Unspecified Infection8
SenSight models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SenSight™ B3300542Stimulator, thalamic, epilepsy, implanted3 deaths130 reports
- SenSight™ B3300542MStimulator, thalamic, epilepsy, implanted3 deaths115 reports
- SenSight™ B3301542Stimulator, electrical, implanted, for essential tremor3 deaths77 reports
- SenSight™ B31061implanted subcortical electrical Stimulator (motor disorders)1 recall20 reports
- SenSight™ B31030INSTRUMENT, SURGICAL, NON-POWERED1 recall7 reports
- SenSight™ B3301542MStimulator, electrical, implanted, for essential tremor3 deaths43 reports
- SenSight™ B3400060MStimulator, thalamic, epilepsy, implanted26 reports
- SenSight™ B32000Stimulator, thalamic, epilepsy, implanted22 reports
- SenSight™ B3400060Stimulator, electrical, implanted, for parkinsonian symptoms20 reports
- SenSight™ B3300533Stimulator, thalamic, epilepsy, implanted14 reports
- SenSight™ B3300533Mimplanted subcortical electrical Stimulator (motor disorders)14 reports
- SenSight™ B31000Stimulator, thalamic, epilepsy, implanted8 reports
- SenSight™ B31040Stimulator, thalamic, epilepsy, implanted8 reports
- SenSight™ B3400095Stimulator, electrical, implanted, for parkinsonian tremor2 reports
- SenSight™ B3301533Stimulator, electrical, implanted, for parkinsonian symptoms1 report
- SenSight™ B3301533MStimulator, electrical, implanted, for parkinsonian tremor1 report
- SenSight™ B3400095MStimulator, electrical, implanted, for essential tremor1 report
- SenSight™ B31030INSTRUMENT, SURGICAL, NON-POWERED1 report
Recent SenSight adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionSep 29, 2026Material Deformation
It was reported that lead was identified as bent before implant - surgeon asked for replacement. No known external factors contributed to this issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933218 ↗MalfunctionSep 29, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931877 ↗InjurySep 29, 2026Impedance Problem
It was reported that impedances were out of range when tested in the operating room, with red contacts noted on contacts 2c and 3 after the lead was placed. The HCP and manufacturer representative attempted multiple troubleshooting steps, including removing and wiping down the lead, but the impedances did not clear. The lead was removed and replaced with a second lead, which showed good impedances. The issue was resolved following surgical intervention, and no further information was available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927276 ↗MalfunctionSep 25, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892673 ↗MalfunctionSep 22, 2026Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854747 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Intracranial Hemorrhage
MAUDE report 50841962 ↗InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient had surgery in April and there was a complication during surgery, an intracranial hemorrhage so patient was in rehab for 3 months so the process has been very challenging, they are just getting started learning about the equipment. Additional information received from HCP confirming intracranial hemorrhage was related to implant of bilateral intracranial DBS leads for treatment of Parkinson's disease including ICU stay to determine if from MER microelectrode or macro. Implant surgery occurred on (b)(6) 2026. Supportive care was given to address this, patient is reported to be improving.
Patient problems: Intracranial Hemorrhage
MAUDE report 50841902 ↗MalfunctionSep 18, 2026Break
It was reported that the electrode was damaged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817863 ↗MalfunctionSep 16, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793143 ↗MalfunctionAug 19, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50328033 ↗MalfunctionAug 18, 2026Break; Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307594 ↗MalfunctionJul 10, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785410 ↗MalfunctionJul 9, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25770438 ↗MalfunctionJul 1, 2026High impedance
IT WAS REPORTED THAT UNEXPLAINED ABNORMAL IMPEDANCE VALUES WERE OBSERVED DURING EVALUATION OF THE IMPLANTED SYSTEM. TROUBLESHOOTING STEPS INCLUDED SWITCHING THE EXTENSION CONNECTION AT THE IMPLANTED PULSE GENERATOR; HOWEVER, THE ELEVATED IMPEDANCE VALUES REMAINED ON THE SAME SIDE. THE EXTENSION WAS THEN REMOVED, CLEANED, DRIED, AND REINSERTED AT BOTH THE GENERATOR AND CRANIAL CONNECTION POINTS, BUT HIGH IMPEDANCE VALUES PERSISTED ACROSS ALL CONTACTS. A NEW EXTENSION WAS SUBSEQUENTLY CONNECTED, AFTER WHICH IMPEDANCE VALUES WERE WITHIN NORMAL LIMITS. NO ENVIRONMENTAL OR PATIENT-RELATED CONTRIBUTING FACTORS WERE IDENTIFIED, AND THE ISSUE WAS RESOLVED FOLLOWING REPLACEMENT OF THE EXTENSION. THE HEALTHCARE PROFESSIONAL REPORTED THAT NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25676235 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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