miraDry MD4000-MCRecalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00853419006008), received between Nov 1, 2017 and Jan 30, 2026 — classified as 97 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THIRD DEGREE BURNS REQUIRING DEBRIDEMENT AND A SKIN GRAFT SURGERY.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 24228761 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RETURNED TO CLINIC WITH LINGERING NUMBNESS IN LEFT AXILLA 11 MONTHS AFTER RECEIVING SECOND MIRADRY TREATMENT. REFERRED TO A HAND ORTHOPEDIST.

  Patient problems: Neuropathy

  MAUDE report 23936893 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINING OF AN APPROXIMATELY 1 CM BURN IN THE LEFT AXILLA. GENTACIN OINTMENT WAS APPLIED AT THE CLINIC, AND PROSTANDIN OINTMENT WAS APPLIED AT HOME FROM (B)(6) 2025 TO (B)(6) 2025. AS OF (B)(6) 2025 THE AFFECTED AREA IS COVERED WITH A SCAB AND THE SYMPTOMS HAVE IMPROVED. MEDICATION HAS BEEN DISCONTINUED.

  Patient problems: Burn(s)

  MAUDE report 22256849 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINING OF POST INFLAMMATORY ULCERS ON LEFT AXILLA ARM POST TX. ON (B)(6) 2025 SEE UPDATE: ULCERATIVE LESION WAS OBSERVED. SURGICAL DEBRIDEMENT WAS CONDUCTED, FOLLOWED BY SALINE IRRIGATION AND PROTECTION WITH APPROPRIATE DRESSING. THE PATIENT CONDITION HAS IMPROVED AND THIS WILL NOT BE REPORTED TO REGULATORY AUTHORITIES.

  Patient problems: Skin Erosion

  MAUDE report 22028013 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED IN STATING SHE IS EXPERIENCING LUMPS/NODULES TENDER TO THE TOUCH. PT RETURNED TO DR OFFICE AND WAS ADMINISTERED 1 ROUND OF CORTISOL SHOT.

  Patient problems: Swelling/ Edema

  MAUDE report 21683706 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED SWELLING (EDEMA) IN BILATERAL AXILLA AND PECTORAL REGION, AREA ADJACENT TO UNDERARMS ONE WEEK POST TX. PATIENT PLACED ON IB 800MG AND ZYRTEC 10MG.

  Patient problems: Abscess

  MAUDE report 21164160 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED INFECTION ON RIGHT AXILLA 2 WEEKS POST TX. PATIENT WAS TREATED WITH ANTIBIOTICS AND TOPICAL OINTMENTS AND ISSUE WAS RESOLVED.

  Patient problems: Swelling/ Edema

  MAUDE report 21159808 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD FIRST MD TX IN (B)(6) 2023 AND CALLED THE CLINIC LAST WEEK STATING SHE HAD SOME BUMPS UNDER BOTH AXILLA SINCE 1 MONTH. PATIENT STATES BOTH BUMPS ARE THE SAME SIZE (SMALL EGG) AND IT FEELS SENSITIVE UPON TOUCH AND MOVEMENT. PATIENT HAS NO OTHER SYMPTOMS. PT HAD FOLLOW UP WITH DOCTOR WHO PERFORMED ELLIPTICAL BIOPSY-FIBROSCAR REARRANGEMENT AND TREATED THE PT WITH KENALOG INJECTION ON (B)(6).

  Patient problems: Swelling/ Edema

  MAUDE report 21158404 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED EMAIL FROM REP STATING THE PATIENT IS EXPERIENCING 10/10 NERVE & DISCOMFORT BILATERAL THAT IS ONGOING POST 2ND TX.. PATIENT WAS RX GABAPENTIN AND MEDROL DOSE PACK AND ADVISED TO MASSAGE AND STRETCH.

  Patient problems: Swelling/ Edema

  MAUDE report 21154367 ↗
• InjuryApr 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ¿ COMPLAINT FROM PATIENT 1. FROM SHOULDER TO THE WRIST, SHE FEELS THE SENSATION OF WATER FLOWING. 2. WHEN SHE MAKES A DOWN POSITION OF HER ARM, FEELS TINGLING. HOWEVER, WHEN SHE RAISE HER ARM SHE DOES NOT FEEL TINGLING. 3. 1-2 MONTHS POST THE TREATMENT, SHE FELT SEVERE PAIN THROUGHOUT HER ARMS BUT IT WAS RESOLVED. SOMETIMES SHE FEELS SPONTANEOUS PAIN. ¿ ASSESSMENT BY DOCTOR 1. 09/MAY/23 : DOCTOR RECOMMENDED TO WAIT 6-12MONTHS 2. 03/MAR/24 : A DOCTOR WHO PERFORMED THE TREATMENT LEFT A CLINIC SO DR. KIM TOOK OVER THE PATIENT TO ASSESS. THERE WAS NO VISIBLE TIGHT BAND ON BOTH ARMS. PATIENT COMPLAINT ABOUT 2 SMALL NODULES ON RT. UNDERARM BUT DOCTOR COULD SEE BASED ON HIS ASSESSMENT. PATIENT STILL COMPLAINS ABOUT TINGLING SENSATION WHEN SHE DOWN HER BOTH ARMS.

  Patient problems: Numbness

  MAUDE report 19174345 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD TREATMENT ON (B)(6) 2024. THE BURNS DID NOT APPEAR UNTIL 2/3. CUSTOMER FOLLOW UP IN PERSON ON 2/21. ON 2/5, MUPIROCIN WITH PRESCRIBED FOR BURNS. PATIENT HAS BEEN CLEANING AREA WITH ANTIBACTERIAL SOAP TWICE DAILY AND APPLYING MUPIROCIN.

  Patient problems: Burn(s)

  MAUDE report 18825939 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3RD DEGREE BURN. POST TX CLEANSED WITH ALCOHOL AND APPLIED BACITRACIN ON TOP OF AREA TREATED. PT WAS TO CLEANSE TREATED AREA W HIBICLENSE AND THEN APPLIED BACITRACIN 2X THAT DAY, THEN 3XS NEXT DAY. PT WAS GIVEN 500MG IBOPROFEN, AND TOLD TO TAKE EVERY 4 HRS FOR DAY ONE.

  Patient problems: Burn(s)

  MAUDE report 18553572 ↗
• InjuryJan 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT SIDED ULCERATIONS FOLLOWING TREATMENT AM/PM CLEANSING WITH GENTLE SOAP FOLLOWED BY ANTIBIOTIC OINTMENT FOR 4 DAYS; FOLLOWED UP WITH MD AND WAS PRESCRIBED DOXYCLYCLINE.

  Patient problems: Abscess

  MAUDE report 18440050 ↗
• InjuryOct 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER HAD ABSCESS AND INFECTION IN UNDERARM AFTER TREATMENT. PATIENT WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Abscess

  MAUDE report 17862065 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED A COMPLAINT FORM FROM TIM STATING ON 7/30 A TREATMENT WAS COMPLETED, HOWEVER DURING THE PATIENTS RETURN VISIT IT WAS NOTICED THE PATIENT HAD BURNS.

  Patient problems: Burn(s)

  MAUDE report 17712125 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) - PATIENT INFORMED ACCOUNT OPEN WOUND AND PAINFUL, MUPIROCIN BID, OTC IBUPROFEN AND LIDOCAINE CREAM. (B)(6)- PATIENT REPORT TO ACCOUNT THAT IT WAS PAINFUL NOT IMPROVING.

  Patient problems: Abscess

  MAUDE report 17470260 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED AN INFECTION THAT RESULTED IN AN ULCER THAT NEEDED TO BE DRAINED TWICE AND WAS PUT ON MULTIPLE COURSES OF ANTIBIOTICS.

  Patient problems: Skin Erosion

  MAUDE report 16995303 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS REPORTED THAT THEY WERE EXPERIENCING NUMBNESS IN THEIR UPPER EXTREMITIES TWO YEARS POST TX.

  Patient problems: Numbness

  MAUDE report 16943815 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED BURNS POST TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 16560078 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED BURNS POST TREATMENT.

  Patient problems: Burn(s)

  MAUDE report 16559979 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCING BURNS POST TREATMENTS.

  Patient problems: Burn(s)

  MAUDE report 16556951 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED BURNS AT THE TOP PART OF THE AXILLA. THE PATIENT IS REQUESTING AN FSE TO GO ONSITE TO ENSURE THE SYSTEM IS WORKING PROPERLY.

  Patient problems: Burn(s)

  MAUDE report 16554766 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED BURNS AT THE TOP PART OF THE AXILLA.

  Patient problems: Burn(s)

  MAUDE report 16554182 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEY HAVE HAD AN INFECTION SINCE THEIR PROCEDURE. THE PATIENT WAS PRESCRIBED DOXYCYCLINE AND CEPHALEXIN FOR 10 DAYS. HER PCP HAS DRAINED THE PUS AND THE INFECTION WOULD TEMPORARILY GO AWAY BUT HAS ALWAYS RETURNED.

  Patient problems: Skin Infection

  MAUDE report 16491258 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT DEVELOPED CELLULITIS TO LEFT AXILLA. THE PATIENT NEEDED ANTIBIOTICS (DOXYCYCLINE & KEFLEX) & WOUND CARE FOR THEIR ABSCESS. THE ISSUE IS RESOLVING.

  Patient problems: Cellulitis

  MAUDE report 16419159 ↗