Revi™ System Patient Kit KA-9000-0001_US_CMRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07290017912226), received between Mar 29, 2025 and Sep 12, 2025 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Electrical Shorting” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHILE THE FCS WAS AT THE HOSPITAL FOR ANOTHER IMPLANT, THE PHYSICIAN SAYS SHE IS EXPLANTING REVI FOR THIS PATIENT AS THE NEXT CASE. THE FCS WAS ABLE TO COLLECT THE DEVICE AND BY RMA AND BIOHAZARD KIT USED TO SEND IT BACK. THIS WAS THE PATIENT'S DECISION DUE TO NOT HAVING RELIEF. HER EXTREME EDEMA IN BOTH LEGS MADE IT VERY DIFFICULT TO PROPERLY DIRECT STIM, AND THE PATIENT WOULD FEEL TINGLING ON TOP OF HER FOOT AND IN HER ACHILLES AREA.

  Patient problems: Insufficient Information

  MAUDE report 23045600 ↗
• MalfunctionAug 28, 2025Failure to Deliver Shock/Stimulation; Failure to Interrogate; Failure to Deliver Shock/Stimulation; Failure to Interrogate

  THE PATIENT REPORTS THAT SHE HAS NOT BEEN ABLE TO INITIATE TREATMENTS FOR THE LAST COUPLE OF DAYS. SHE CHARGES HER ECU, SHE GETS RAPID BEEPING, BUT WHEN SHE PRESSES THE POWER BUTTON THERE IS NO RESPONSE, THERE IS NEVER A SWITCH TO THE GREEN LIGHT. PS DID A HARD RESET WITH THE PATIENT, THEN WHEN THE PATIENT ATTEMPTED TO START A TREATMENT SHE REPORTED HEARING CLICKING NOISES FROM THE WEARABLE, THEN A RED LIGHT, THEN THE DEVICE SHUT OFF.

  Patient problems: Insufficient Information

  MAUDE report 22919077 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CAME INTO THE OFFICE FOR A 6-MONTH FOLLOW-UP VISIT. SHE SAID THAT SHE HAS BEEN EXPERIENCING PAIN DOWN HER FOOT BELOW THE INCISION SITE AND THAT HER HEEL IS NUMB. SHE WANTS THE IMPLANT REMOVED. SHE IS LOOKING TO SCHEDULE THE IMPLANT REMOVAL FOR THE MIDDLE OF AUGUST. SHE ALSO STATED THAT SHE HAD A LOT OF DIFFICULTY WITH THE WEARABLE AND THAT IT WOULD TAKE HER OVER AN HOUR TO COMPLETE A TREATMENT BECAUSE IT CONSISTENTLY TIMED OUT. SHE STOPPED USING IT ALTOGETHER OVER A MONTH AGO.

  Patient problems: Pain

  MAUDE report 22900883 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED AND REPORTED SHARP BURNING PAIN IN ANKLE NEAR INCISION SITE. SHE SAID THE PAIN STARTED LAST NIGHT, (B)(6) 2025 AROUND 9:30PM AND SHE TOOK HER SLEEPING PILLS THAT HELPED HER GO TO BED. PAIN WOKE HER UP AT 3AM AND SHE HAD TO TAKE OTC PAIN MEDICATION TO GO BACK TO BED. SHE DESCRIBES THE PAIN TO BE AN 8 OUT OF 10 WHEN PRESENT. TODAY THE PAIN HAS BEEN OFF AND ON AND NOT TRIGGERED BY ANY CERTAIN ACTIVITY. SHE DID HAVE AN APPT WITH DR. (B)(6) AND SHE SAID THE INCISION LOOKS GOOD AND NOT SURE WHAT MAY BE CAUSING PAIN. SHE WAS PRESCRIBED GABAPENTIN FOR PAIN WHICH SHE WILL TAKE TODAY. SHE WAS IMPLANTED ON (B)(6) AND YET TO BE ACTIVATED. (B)(6) ADVISED PATIENT TO FOLLOW DR. (B)(6) INSTRUCTIONS OF RESTING, ELEVATING LEG AND TAKING PRESCRIBED MEDICATION OF GABAPENTIN.

  Patient problems: Implant Pain

  MAUDE report 22869143 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT SINCE ACTIVATION, THE PATIENT HAS HAD INCIDENTS OF "TREMORS" AND "SHOCKING" SEVERAL TIMES WHILE DOING TREATMENTS. THE FIRST TIME, THE PATIENT WENT TO THE ER, AND THE TREMORS WERE DOCUMENTED. A WEEK LATER, SHE EXPERIENCED BOTH TREMORS IN HER ARMS AND A SHOCKING NEAR THE IMPLANT SITE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 22844212 ↗
• InjuryAug 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT, (B)(6), CALLED TO REPORT NUMBNESS IN HER TOE ON HER LEFT FOOT DURING THE 2ND AND 3RD TREATMENT SESSIONS AND AFTER. SHE REPORTS FIRST FEELING NUMBNESS IN HER TOES DURING THE TREATMENT SESSION ON (B)(6). THE NUMBNESS DID NOT SUBSIDE UNTIL THE NEXT DAY.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 22835909 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT SWELLING FOLLOWING TREATMENT. FCS REPORTED :PATIENT REPORTS ANKLE SWELLING SOON AFTER USE OF THE DEVICE, AND SWELLING DOES NOT SUBSIDE FOR DAYS. PICTURES ARE SENT FROM PATIENT PROVIDED TO FCS.

  Patient problems: Peripheral Edema; Swelling/ Edema

  MAUDE report 22790179 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTED AS DELAYED HEALING. THE PHOTO SHOWS SCABBING OF THE WOUND. THERE HAVE BEEN SIGNS OF IMPROVEMENT AT TIMES; HOWEVER, THE IMPROVEMENT HAS OFTEN BEEN SHORT-LIVED, AND THE INFECTION HAS RETURNED EVEN AFTER MULTIPLE ROUNDS OF ANTIBIOTICS. EXPLANATION COMPLETED. DURING THE EXPLANTATION, IT DID NOT APPEAR THAT THE ACTUAL IMPLANT WAS INFECTED WHEN TAKEN OUT, AND IT WAS FULLY ENCAPSULATED. DATE OF EXPLANT ON (B)(6) 2025.

  Patient problems: Granuloma; Skin Inflammation/ Irritation

  MAUDE report 22779259 ↗
• MalfunctionMar 29, 2025Intermittent Continuity; Electrical Shorting; Intermittent Continuity; Electrical Shorting

  IT WAS REPORTED THAT THE PATIENT HAD PLUGGED THE EXTERNAL COMMUNICATION UNIT IN TO CHARGE AND LATER FOUND IT TO BE SMOKING, WITH SMALL FLAMES COMING FROM THE CONNECTION BETWEEN THE UNIT AND CHARGING CABLE. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21727558 ↗