Activa RCRecalls & reported problems across all models

We found 8 models of Activa RC by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 6,131 adverse event reports in the FDA's MAUDE database, received between Nov 8, 2016 and Sep 28, 2026 — classified as 7 deaths, 1,138 injuries, 4,986 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1,727 reports).

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

Most reported Activa RC problems

Activa RC models

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

• ACTIVA RC 37612

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
  2,839 reports
• Activa® RC 37612

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
  2 deaths1,849 reports
• Activa® RC 37612

  Stimulator, electrical, implanted, for parkinsonian symptoms
  1 death469 reports
• Activa® RC 37612

  Stimulator, electrical, implanted, for parkinsonian symptoms
  410 reports
• Activa® RC 37612

  Stimulator, electrical, implanted, for parkinsonian tremor
  2 deaths371 reports
• Activa® RC 37612

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
  2 deaths188 reports
• Activa® RC 37612

  Stimulator, electrical, implanted, for parkinsonian symptoms
  3 reports
• ACTIVA RC 37612

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
  2 reports

Recent Activa RC adverse event reports

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

• InjurySep 28, 2026Energy Output Problem; Inappropriate/Inadequate Shock/Stimulation; Connection Problem

  Patient problems: Electric Shock; Paresthesia

  MAUDE report 50924442 ↗
• MalfunctionSep 28, 2026Device Difficult to Program or Calibrate; Therapeutic or Diagnostic Output Failure

  It was reported that patient went to orchestra rehearsal at lunchtime today and turned up the stimulation to have better tremor control. When rehearsal was over, patient went to turn the stimulation down and received a symbol on the programmer with a doctor on it telling patient to call their doctor. Patient said that has tried several times and continues to get the message. When asked, patient does have her programmer with her at the time of the call. Patient connected and reviewed call doctor screen and said OOR was listed below. Reviewed meaning of the message and with instruction patient was able to connect to implant and get beyond the screen and lowered the setting. The troubleshooting steps that were taken on the call resolved the issue. Patient to monitor if this occurs after increases again and if so, patient was directed to report to their managing physician. Patient called back regarding previously reported events. Patient stated that their "remote control" could not turn their DBS off, and they are encountering a screen with a doctor and said OOR. Agent tried to have them decrease and increase the stimulation but the issue persists. Agent redirected them to the HCP to f

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916600 ↗
• MalfunctionSep 28, 2026Migration or Expulsion of Device; Patient Device Interaction Problem

  It was reported that the implantable neurostimulator (INS)  on the patient's left side seemed like it moved around a lot more than the INS in their right side. Patient stated that their cat jumped on their chest when they're sleeping and danced around with a lot of motion and patient thought this may have caused the INS to move more. Patient added that the INS gradually moved more and that the issue happened maybe 5 or several years ago. Patient mentioned that their INS was located on their left side about parallel with the line at the top of their breast, and that they also had another INS on the right side of their collar bone area. Agent redirected the patient to their HCP to further address the issue. When asked for HCP info.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914638 ↗
• MalfunctionSep 23, 2026Display or Visual Feedback Problem; Battery Problem; Operating System Becomes Nonfunctional

  It was reported that when they pulled the recharger out and put it on the dock, prior to starting a charging session with the implant, the green lights started scrolling rapidly. Off the dock, they said it was dead. Recharger is unresponsive on the dock. Caller said patient hadn't charged the implant in two weeks so they were hoping to get the patient charged up as soon as possible. Caller said they called they'd looked online for troubleshooting and called the manufacturer company representative this morning however both resources told them to call Patient Services (PS). PS had the caller check the status of the dock and the caller confirmed that the green light was solid when the cable was plugged in and that the light would not flicker if they moved the dock around. Patient services had the patient place the recharger on the dock and hold the power button down for ten seconds but that did not resolve. Caller took recharger off the dock and PS had the caller do a recharger reset, however the issue was not resolved through troubleshooting. Recharger maintenance considerations were reviewed with the caller and the caller said they hadn't realized they needed to always have the rech

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865555 ↗
• MalfunctionSep 22, 2026Battery Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860501 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860428 ↗
• MalfunctionSep 22, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856645 ↗
• MalfunctionSep 22, 2026Display or Visual Feedback Problem; Failure to Power Up

  It was reported that reason for call was to report that the recharger won't turn on and the battery lights are scrolling up and down since yesterday. Caller said that patient recharges once a week and in between recharge sessions keeps the recharger in the case. Reviewed recommendation to keep recharger in plugged in dock in between recharge sessions. Reviewed troubleshooting steps twice however issue was not resolved. Replacement request was sent to repair to replace the recharger. Caller did say that patient needs to recharge. Caller was directed to contact managing physician's office to check if they can go there to recharge patient's implant.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50851339 ↗
• InjurySep 21, 2026Delayed Charge Time; Insufficient Device Problem Information

  It was reported that patient states recharging is taking longer and she occasionally feels a baby is kicking around her abdominal implant. Manufacturer representative (rep) did an impedance check, impedance check showed within range.  Patient received a letter that her battery might be outdated. A battery replacement was scheduled. Rep reports issue was resolved. Additional information was received from manufacturer representative (rep). Rep reported the cause of the recharging taking longer was unknown. Rep reports the implantable neurostimulator (INS) was replaced and the issue was resolved. Rep clarified the feeling of a baby kicking was referring to the patient thinking there was a device issue. Information was confirmed by a physician.

  Patient problems: Insufficient Information

  MAUDE report 50841705 ↗
• MalfunctionSep 21, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841224 ↗
• InjurySep 17, 2026Failure to Deliver Energy

  Patient problems: Fall

  MAUDE report 50811366 ↗
• InjurySep 17, 2026Electromagnetic Compatibility Problem

  It was reported that patient said their DBS therapy feels less effective when they play video games and use their washing machine. There are no known contributing factors. All impedances were checked and were in range. This issue is considered resolved.

  Patient problems: Insufficient Information

  MAUDE report 50802948 ↗
• MalfunctionSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that caller had a frayed recharger antenna.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50799106 ↗
• MalfunctionSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the device was returned with no known allegation, analysis found non-conformance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797931 ↗
• InjurySep 16, 2026Failure to Deliver Energy

  Patient problems: Memory Loss/Impairment

  MAUDE report 50794607 ↗

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