Revi™ Implant MA-1007-0600_US_CMRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07290017912011), received between Aug 22, 2024 and May 18, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Defibrillation/Stimulation Problem” (2 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, 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2026Defective Device

  PATIENT EXPERIENCED ELECTRICAL SHOCKS WHEN USING THE DEVICE.

  Patient problems: Electric Shock

  MAUDE report 25202088 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED AN INFECTION AT THE INCISION SITE THAT WORSENED OVER TIME. DURING A PHYSICIAN VISIT, BLISTERS AND DRAINAGE WERE OBSERVED. UPON EXAMINATION AND PRESSURE APPLIED TO THE INCISION SITE, THE IMPLANT SPONTANEOUSLY EXTRUDED.

  Patient problems: Implant Pain

  MAUDE report 25200987 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS EXPERIENCING SEVERE PAIN AT THE IMPLANT SITE AND REQUESTED EXPLANTATION OF THE DEVICE. THE PATIENT WAS ALSO DIAGNOSED WITH SEVERE VENOUS INSUFFICIENCY AND WAS LIKELY NOT AN IDEAL CANDIDATE FOR REVI.

  Patient problems: Implant Pain

  MAUDE report 25200928 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED OOZING AROUND THE INCISION SITE ACCOMPANIED BY PAIN. ANTIBIOTIC TREATMENT WAS INITIATED; HOWEVER, THE PATIENT CONTINUED TO EXPERIENCE PAIN, AND THE INCISION REMAINED IRRITATED WITH ONGOING OOZING. A DECISION WAS MADE TO REMOVE THE IMPLANT.

  Patient problems: Implant Pain

  MAUDE report 25200923 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAS AN INFECTION AND BELIEVES THERE IS NO RELATION TO THE IMPLANT OR REVI. PATIENT HAS HAD URETHRAL BLEEDING AND WORRIED ABOUT BLADDER CANCER AN BELIEVES CO MORBIDITIES WAS THE ISSUE. SHE IS PROBABLY NOT A GOOD CANDIDATE FOR SURGERY IN GENERAL WITH HER CO MORBIDITIES.

  Patient problems: Post Operative Wound Infection

  MAUDE report 25200662 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT SHE HAD STOPPED USING THE REVI DEVICE IN EARLY (B)(6) 2026 DUE TO FEELING TINGLING, NUMBNESS AND PAIN IN HER LEFT LEG FROM THE BOTTOM SOLE OF FOOT UP TO LEFT BUTTOCK. SHE REPORTS THESE SYMPTOMS TO HAVE STARTED AROUND EARLY (B)(6) 2025. SHE THEN STOPPED USING REVI IN (B)(6) 2026 UNSURE IF IT WAS CAUSED BY REVI. SHE DID NOT SEE ANY DIFFERENCE IN SYMPTOMS OR SEVERITY WHEN STOPPING REVI TREATMENTS. SHE DENIES ANY REDNESS, INFLAMMATION OR WARMTH AT INCISION SITE. SHE WAS DIAGNOSED WITH NEUROPATHY, BUT THE CAUSE IS STILL UNKNOWN. SHE WAS PRESCRIBED MEDICATION FOR THE NEUROPATHY AND PAIN.

  Patient problems: Neuropathy

  MAUDE report 25032607 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2025. ON (B)(6) 2026, BWM WAS INFORMED THAT THE PATIENT EXPERIENCED DELAYED WOUND HEALING, INFLAMMATION, AND A POTENTIAL INFECTION AT THE INCISION SITE. THE PATIENT WAS TREATED WITH TWO COURSES OF ANTIBIOTICS, AFTER WHICH THE INCISION COLOR RETURNED TO NORMAL; HOWEVER, AN OPENING REMAINED AT THE INCISION SITE. THE TREATING PHYSICIAN SUBSEQUENTLY EVALUATED THE INCISION AND DETERMINED THAT IT WAS HEALING APPROPRIATELY, WITH NO RESTRICTIONS ON ACTIVITIES, INCLUDING POOL USE. THE PATIENT WAS ADVISED TO CONTINUE REVI TREATMENT. AS OF (B)(6) 2026, THE INFECTION APPEARED TO BE RESOLVED FOLLOWING ANTIBIOTIC TREATMENT, WITH NO REMAINING CONCERNS REPORTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24746352 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED ON (B)(6) 2026. ON 04 MARCH 2026, BWM BECAME AWARE THAT THE PATIENT DEVELOPED MILD CELLULITIS. AS A RESULT, TREATMENT WAS SUSPENDED, AND THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS. ON (B)(6) 2026, THE PATIENT WAS REFERRED FOR WOUND CARE, WHERE THE INCISION SITE WAS TREATED WITH A SILVER ALGINATE DRESSING.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24745030 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "SHE HAS BEEN FEELING "SLIGHT STINGING/BURN" AT IMPLANT SITE WHEN NOT TREATING THE "LAST COUPLE OF WEEKS, BUT IT HAS GOTTEN BETTER" "ANKLE SEEMS SWOLLEN AND YELLOW AROUND INCISION" SHE HAS JUST SEEN HER PCP WHO SAID THE INCISION DID NOT APPEAR INFECTED. I ASKED FOR PHOTO TO BE SENT TO MYSELF AND TO NOTIFY DR. FERULIC WITH CONCERNS AS WELL AS A PHOTO. I ASKED HER TO STOP TREATING HERSELF IF THE "STINGING/BURN" CONTINUES OR EXPERIENCING ANY DISCOMFORT. "

  Patient problems: Skin Burning Sensation; Undesired Nerve Stimulation

  MAUDE report 22683327 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT STATES HE WENT TO THE ER (B)(6) DUE TO INFECTION AT THE INCISION SITE. HE WAS GIVEN ANTIBIOTICS AND SENT HOME TO SCHEDULE EXPLANT AS ER DOCTOR WAS HESITANT TO EXPLANT DUE TO PATIENT BEING ON BLOOD THINNERS. PATIENT CALLED TO INFORM HE IS BEING EXPLANTED (B)(6) AT 7:15AM BY DR. (B)(6). HE IS A PATIENT OF DR. (B)(6), BUT DR. (B)(6) IS OUT OF TOWN. ON (B)(6) 2025: PATIENT WAS EXPLANTED WITHOUT ISSUES; A CULTURE WAS TAKEN DUE TO ACTIVE INFECTION; PATIENT WAS GIVEN 7-DAY COURSE OF ANTIBIOTICS POST-SURGERY AND WILL FOLLOW UP IN CLINIC (B)(6) WITH (B)(6), DR. (B)(6) PA. PATIENT IS LEAVING FOR A CRUISE VACATION (B)(6). PATIENT WANTED TO TRY TO SALVAGE IMPLANT, BUT DR. (B)(6) THOUGHT BEST TO EXPLANT DUE TO PATIENT'S UPCOMING CRUISE. IMPLANT WAS COLLECTED IN A BIOHAZARD BAG.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22672220 ↗
• InjuryJul 23, 2025Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  PT REPORTS SHE WORKS AT A PRESCHOOL AND WHILE PLAYING ON THE FLOOR WITH CHILDREN, THEY STEPPED ON HER LEG NEAR THE AREA OF HER IMPLANT. SHE REPORTED SOME ACUTE SORENESS IN THE AREA BUT INITIALLY NO PAIN WITH STIMULATION (THIS WAS ABOUT A WEEK AGO). THIS MORNING FCS RECEIVED A TEXT FROM THE PATIENT REPORTING DIFFICULTY CONNECTING THE WEARABLE TO HER IMPLANT AND SEVERE PAIN WITH STIMULATION."

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 22581828 ↗
• InjuryJul 18, 2025Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  PATIENT CALLED TO REPORT FOR THE PAST FEW WEEKS WHEN SHE INITIATES TREATMENT, SHE GETS A "BOLT OF PAIN", SUFFICIENTLY UNCOMFORTABLE SHE HAS STOPPED USING THE DEVICE. THE PROBLEM BEGAN ABOUT SIX WEEKS AGO; SHE COULD NOT THINK OF ANY CHANGE OR EVENT THAT MIGHT HAVE PRECIPITATED THE PROBLEM. PS ADVISED HER TO STOP USING THE WEARABLE WHILE THE BLUEWIND MEDICAL INVESTIGATE.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 22542664 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BLUEWIND MEDICAL EMPLOYEE MADE AWARE OF INFECTION AND DEVICE REMOVAL COMPLETED APPROXIMATELY ON 08 NOVEMBER 2024. PER THE PHYSICIAN, STITCHES WERE REMOVED BECAUSE THE WOUND OPENED, HAD PUS AND COULD NOT WALK. PATIENT WENT TO HOSPITAL FOR IV ANTIBIOTICS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20909332 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN REACHED OUT TO BLUEWIND MEDICAL-REP TO NOTIFY THAT PATIENT IS INFECTED AND SHE WILL BE EXPLANTED IMPLANT THE NEXT DAY. PHYSICIAN REPORTED THE FOLLOWING: PATIENT HAD BEEN SEEN AT LEAST TWICE IF NOT 3 TIMES POST OP AND WAS ON HER THIRD COURSE OF ANTIBIOTICS AND WAS PROGRESSING. ACCORDING TO MD, PURULENCE WAS EMANATING FROM THE WOUND AND SIGNS OF PROXIMAL INFECTION UP THE LEG WERE PRESENT IN ADDITION TO PERSISTENT PAIN. MD MADE CLINICAL DECISION TO EXPLANT. BLUEWIND MEDICAL CHIEF MEDICAL OFFICER NOTES BASED ON PICTURES TAKEN BEFORE AND DURING EXPLANT: PHOTOS SHOWED NO SIGN OF PROXIMAL EXTENSION, NO PURULENCE EITHER SUPERFICIALLY OR DEEP IN THE WOUND. A NORMAL APPEARING IMPLANT LOCATION AND POSITIONS, AND ONLY MILD PERI-INCISIONAL ERYTHEMA. DEVICE WAS EXPLANTED WITHOUT CONSEQUENCE. MD MADE COMMENTS AS TO ESSENTIALLY NON-PROBLEMATIC WOUND APPEARANCE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20589983 ↗
• InjuryOct 29, 2024Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  PRE-EXPLANT LEG EVALUATION - MILD EDEMA DISTAL TO THE IMPLANTATION LOCATION. SCAR LOOKS CLEAN. NO ERYTHEMA OR PAIN UPON PALPATION, SCARRING TISSUE IS EVIDENT FROM PREVIOUS SURGERIES ON THE LEG. EXPLANTATION SUMMARY: IMPLANT FOUND AT 4MM DEPTH - CAPSULE INCISED SHARPLY AND SUTURES REMOVED. CLEAR FLUID WAS NOTICED IN THE CAPSULE AND SAMPLED FOR C&S (WAITING FOR RESULTS) CONCLUSION (AGREED WITH HCP): PATIENT SELECTION WAS INAPPROPRIATE. PATIENT WITH CP AND MOTOR DIFFICULTIES + IMPLANTATION AREA DEFORMED/SCARRED DUE TO PREVIOUS SURGERIES (BILATERALLY) NO SIGNS OF INFECTION OR HARM CAUSED BY THE IMPLANT ITSELF.

  Patient problems: Peripheral Edema

  MAUDE report 20559891 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED OPEN WOUND AT INCISION SITE WITH DRAINAGE. THE TREATING PHYSICIAN DETERMINED THERE WERE SIGNS OF INFECTION AND THE FOLLOWING ACTIONS WERE TAKEN: A WOUND CULTURE WAS COMPLETED AND SHOWED 2 STRAINS OF PSEUDOMONAS AERUGINOSA. THE PATIENT WAS PRESCRIBED BACTRIM. THE PHYSICIAN REMOVED THE IMPLANT ON (B)(6) 2024 UNDER IV SEDATION. THE PATIENT IS CURRENTLY RECOVERING WITH NO LONG-TERM COMPLICATIONS ANTICIPATED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 20027277 ↗