ActivaRecalls & reported problems across all models

We found 3 models of Activa by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 3,195 adverse event reports in the FDA's MAUDE database, received between Apr 26, 2013 and Sep 23, 2026 — classified as 14 deaths, 1,076 injuries, 2,105 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (425 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

Activa 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. May 15, 2024Open, Classified

   Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.

   Z-2427-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Activa problems

Activa models

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

• Activa® 37612

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
  1,325 reports
• Activa® 37603

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
  8 deaths1,093 reports
• Activa® 37602

  Deep brain stimulator for obsessive compulsive disorder (OCD)
  1 recall6 deaths777 reports

Recent Activa adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Data Problem

  Patient problems: Insufficient Information

  MAUDE report 50876327 ↗
• MalfunctionSep 23, 2026Delayed Charge Time; Charging Problem

  It was reported that the patient recently started using their DBS again and they said they need to charge it more frequently and for longer periods. Patient said they are very petite, and the charging harness that originally came with their DBS was much too large for and was basically unusable. Currently, the patient's representative helps the patient place the charger inside their shirt and wrap a post-surgical compression band around their chest to help hold it in the correct position. Patient states they also have athetoid cerebral palsy, so involuntary movement makes it especially important that the charger stay securely positioned while they charge. Patient was inquiring about a smaller charging harness, or another accessory compatible with their older rechargeable DBS system that would hold the charger securely in place on a very petite person.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872536 ↗
• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  It was reported that the patient underwent explant of the prior complete DBS system in order to improve outcomes and to make the patient MRI compatible. The patient¿s disease had progressed and the patient was reported to be unilateral only at the time of the event. The surgeon completed bilateral surgery to achieve the best possible outcomes. The issue was considered resolved at the time of the report, and no additional information was available from the healthcare professional.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50304852 ↗
• MalfunctionAug 6, 2026Failure to Deliver Energy; Charging Problem; Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50153556 ↗
• MalfunctionJul 31, 2026Connection Problem; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50097922 ↗
• MalfunctionJul 15, 2026High impedance; Delayed Charge Time

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25827325 ↗
• MalfunctionJul 10, 2026Failure to Deliver Energy

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 25781094 ↗
• MalfunctionJun 15, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN EXTERNAL DEVICE. THE PATIENT'S REPORTED THE PATIENT HAD A BROKEN DESKTOP CHARGER CONNECTOR PIN. A REQUEST WAS SENT TO REPAIR TO REPLACE THE DESKTOP CHARGER. UPON FURTHER CONSIDERATION, REOPENED CASE TO SEND REPAIR REQUEST FOR A 37761 AND THEN CLOSED CASE AGAIN. REPAIR TASK (B)(4) WAS CANCELLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498824 ↗
• MalfunctionJun 4, 2026Battery Problem; Communication or Transmission Problem; Electromagnetic Compatibility Problem

  IT WAS REPORTED THAT FOR THE PAST FEW MONTHS THE PATIENT NOTICED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERIES DIDN'T SEEM TO HOLD A CHARGE AS LONG. THE PATIENT'S MANAGING HEALTHCARE PROVIDER (HCP) TOLD THE PATIENT THAT THE INS BATTERIES MIGHT NOT BE HOLDING A CHARGE AS LONG BECAUSE THEY WILL BE DUE FOR REPLACEMENT BY THE END OF THE YEAR. THE PATIENT ALSO NOTICED THAT THE WIRELESS RECHARGER (WR) SEEMED TO HAVE MORE DIFFICULTY FINDING THE INS BATTERIES AND MAINTAINING A CONNECTION WITH THEM. THE CALLER LIVED OUT OF STATE SO THEY WERE UNABLE TO TROUBLESHOOT, BUT THEY SAID THEY WOULD HAVE THE PATIENT'S FRIEND CALL BACK WHEN THEY ARE WITH THE PATIENT TO TROUBLESHOOT THE COUPLING ISSUE. PATIENT REP CALLED REGARDING THE SAME ISSUE AND MENTIONED PREVIOUSLY REPORTED INFORMATION. CALLER ADDED THAT THEY MAKE SURE THAT THE BULLSEYE ON THE WR WAS ALIGNED WITH THE PATIENT'S IMPLANT WHEN THEY CHARGED, AND THAT THE FLOORING IN THE PATIENT'S BEDROOM WAS MAGNETIZED. DURING THE CALL, AGENT REVIEWED GENERAL DEVICE USE, EMI/MAGNETS COMPATIBILITY INFORMATION AND THERAPY INFORMATION, THEN WALKED CALLER THROUGH CONNECTING TO THE PATIENT'S IMPLANT TO CHECK THE IMPLANT'S BATTERY. CALLER CONFIRMED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399923 ↗
• MalfunctionJun 4, 2026Battery Problem; Communication or Transmission Problem; Electromagnetic Compatibility Problem

  IT WAS REPORTED THAT FOR THE PAST FEW MONTHS THE PATIENT NOTICED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERIES DIDN'T SEEM TO HOLD A CHARGE AS LONG. THE PATIENT'S MANAGING HEALTHCARE PROVIDER (HCP) TOLD THE PATIENT THAT THE INS BATTERIES MIGHT NOT BE HOLDING A CHARGE AS LONG BECAUSE THEY WILL BE DUE FOR REPLACEMENT BY THE END OF THE YEAR. THE PATIENT ALSO NOTICED THAT THE WIRELESS RECHARGER (WR) SEEMED TO HAVE MORE DIFFICULTY FINDING THE INS BATTERIES AND MAINTAINING A CONNECTION WITH THEM. THE CALLER LIVED OUT OF STATE SO THEY WERE UNABLE TO TROUBLESHOOT, BUT THEY SAID THEY WOULD HAVE THE PATIENT'S FRIEND CALL BACK WHEN THEY ARE WITH THE PATIENT TO TROUBLESHOOT THE COUPLING ISSUE. PATIENT REP CALLED REGARDING THE SAME ISSUE AND MENTIONED PREVIOUSLY REPORTED INFORMATION. CALLER ADDED THAT THEY MAKE SURE THAT THE BULLSEYE ON THE WR WAS ALIGNED WITH THE PATIENT'S IMPLANT WHEN THEY CHARGED, AND THAT THE FLOORING IN THE PATIENT'S BEDROOM WAS MAGNETIZED. DURING THE CALL, AGENT REVIEWED GENERAL DEVICE USE, EMI/MAGNETS COMPATIBILITY INFORMATION AND THERAPY INFORMATION, THEN WALKED CALLER THROUGH CONNECTING TO THE PATIENT'S IMPLANT TO CHECK THE IMPLANT'S BATTERY. CALLER CONFIRMED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25399918 ↗
• MalfunctionMay 20, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE DTC CORD'S METAL TIP HAD BROKEN OFF, AND IS NEEDING REPLACEMENT. AGENT REQUESTED A REPLACEMENT DTC CORD THROUGH REPAIR, AND REVIEWED REPLACEMENT PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25225787 ↗
• MalfunctionMay 1, 2026Charging Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT (PT) HAS BEEN HAVING SOME PROBLEMS WITH THEIR BACK. THE CALLER REPORTED THAT THE DBS DEVICES ARE NOT WORKING AND THEY WANT TO KNOW IF THAT IS CAUSING THE BACK PROBLEMS. THE CHIROPRACTOR THINKS THERE IS A CHANCE THAT THE BRAIN CONTROLS THE MOVEMENTS AND BALANCE AND THAT MAYBE THAT COULD BE AFFECTING THE BACK. THE CALLER NOTED THAT THEIR BODY LEANS WAY TO THE LEFT AND THEY ARE WONDERING IF THAT IS CAUSING THE ISSUES THEY ARE HAVING IN THEIR BACK." THE CALLER ALSO NOTED THAT THEY HAD HEART SURGERY ABOUT 2 YEARS AGO AND AFTER THE HEART SURGERY, THEY NOTICED THAT THEY WERE HAVING A HARD TIME GETTING THE GENERATORS CHARGED, SO THEY WERE ONLY CHARGING THEM UP PARTIALLY. AGENT ASKED THE CALLER IF THEY ARE CHARGED AND ON. THE CALLER REPORTED THAT ONE SIDE WAS RECENTLY CHARGED TO 100% BUT THEY ARE NOT SURE IF IT IS ON BECAUSE THEY DO NOT KNOW HOW TO DO THAT. AGENT EXPLAINED THAT IF THEY WERE ALLOWED TO DISCHARGE, THERAPY WOULD BE OFF AND IT WOULD HAVE TO MANUALLY TURN BACK ON AGAIN. THE CALLER WILL CHARGE UP THE DEVICES AND CALL FOR HELP CONFIRMING OR TURNING THEM ON. THE CALLER SEES THE HEALTHCARE PROVIDER (HCP) ON APRIL 27TH AND THEY WILL DISCUSS REPLACEMENTS.

  Patient problems: Insufficient Information

  MAUDE report 25060172 ↗
• MalfunctionMay 1, 2026Charging Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT (PT) HAS BEEN HAVING SOME PROBLEMS WITH THEIR BACK. THE CALLER REPORTED THAT THE DBS DEVICES ARE NOT WORKING AND THEY WANT TO KNOW IF THAT IS CAUSING THE BACK PROBLEMS. THE CHIROPRACTOR THINKS THERE IS A CHANCE THAT THE BRAIN CONTROLS THE MOVEMENTS AND BALANCE AND THAT MAYBE THAT COULD BE AFFECTING THE BACK. THE CALLER NOTED THAT THEIR BODY LEANS WAY TO THE LEFT AND THEY ARE WONDERING IF THAT IS CAUSING THE ISSUES THEY ARE HAVING IN THEIR BACK." THE CALLER ALSO NOTED THAT THEY HAD HEART SURGERY ABOUT 2 YEARS AGO AND AFTER THE HEART SURGERY, THEY NOTICED THAT THEY WERE HAVING A HARD TIME GETTING THE GENERATORS CHARGED, SO THEY WERE ONLY CHARGING THEM UP PARTIALLY. AGENT ASKED THE CALLER IF THEY ARE CHARGED AND ON. THE CALLER REPORTED THAT ONE SIDE WAS RECENTLY CHARGED TO 100% BUT THEY ARE NOT SURE IF IT IS ON BECAUSE THEY DO NOT KNOW HOW TO DO THAT. AGENT EXPLAINED THAT IF THEY WERE ALLOWED TO DISCHARGE, THERAPY WOULD BE OFF AND IT WOULD HAVE TO MANUALLY TURN BACK ON AGAIN. THE CALLER WILL CHARGE UP THE DEVICES AND CALL FOR HELP CONFIRMING OR TURNING THEM ON. THE CALLER SEES THE HEALTHCARE PROVIDER (HCP) ON APRIL 27TH AND THEY WILL DISCUSS REPLACEMENTS.

  Patient problems: Insufficient Information

  MAUDE report 25060141 ↗
• MalfunctionApr 28, 2026Delayed Charge Time

  IT WAS REPORTED THAT PATIENT WAS HAVING A HARD TIME WALKING AGAIN. CALLER SAID THE PATIENT HAD BEEN CHARGING THE IMPLANT EVERY OTHER OR EVERY DAY AND IT WAS TAKING FOREVER TO CHARGE THE IMPLANT. AGENT ASKED, CALLER SAID THE ISSUE HAD BEEN GOING ON FOR A WHILE AND THAT IT HAD BEEN TAKING 6-7 HOURS TO CHARGE. CALLER CONFIRMED THERE WAS NO DAMAGE TO THE RECHARGER. CALLER MENTIONED THAT THEY HAD THE RECHARGING CABLE REPLACED NOT TOO LONG AGO BECAUSE IT WAS BENDING. DURING THE CALL, CALLER WAS ABLE TO START A CHARGING SESSION WITH ALL 8 COUPLING BOXES FILLED IN. AGENT REVIEWED RECHARGING EXPECTATIONS WITH THE CALLER. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.".

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 25020824 ↗
• MalfunctionApr 28, 2026Connection Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE RECHARGER CORD WAS FRAYED. A REPLACEMENT WAS SENT. NO PATIENT SYMPTOMS WERE REPORTED. PATIENT REP CALLED BACK STATING CALLING PREVIOUSLY TO HAVE DESKTOP CHARGER REPLACED AND NOTICED RIGHT WHEN THEY GOT IT THE PIN ON THE END WAS LOOSE. YESTERDAY IT FELL APART WHEN PLUGGING IN. AGENT SENT REQUEST TO REPAIR. THE PATIENT REP CALLED BACK AND REPEATED INFORMATION REGARDING THE BROKEN DTC CONNECTOR PIN REPORTED IN THE FOLLOW UP NOTE FROM 20-APR-2026. THE CALLER WAS EXPECTING THE REPLACEMENT DTC TO BE DELIVERED YESTERDAY, BUT PER FEDEX IT WAS DELIVERED TO THE WRONG ADDRESS. THE CALLER WAS GETTING WORRIED BECAUSE THE PATIENT'S INS BATTERY LEVEL WAS GETTING LOW, AND THEY SAID THE PATIENT COULD END UP IN THE HOSPITAL IF THE THERAPY TURNS OFF. THE CALLER SAID THEY SPOKE WITH MANUFACTURING REP TODAY TO EXPRESS THEIR CONCERN, AND THE REP ADVISED THE CALLER TO CALL PATIENT SERVICES TO SEE IF A REQUEST FOR ANOTHER DTC COULD BE MADE FOR OVERNIGHT DELIVERY. AGENT CHECKED FEDEX TRACKING, WHICH ALIGNED WITH WHAT FEDEX TOLD THE CALLER. AGENT REVIEWED THAT ANOTHER REPAIR REQUEST COULD NOT BE SUBMITTED SINCE THE PACKAGE IS SHOWING AS READY FOR DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25012487 ↗

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