CoolTone 5034Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04053815076698), received between Mar 25, 2020 and Mar 20, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Leak/Splash” (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. How this data works · Data updated Oct 13, 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.

• InjuryMar 20, 2026Leak/Splash

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED A COOLTONE TREATMENT ON (B)(6) 2026 USING THE COOLTONE APPLICATOR ON THE ABDOMEN AREA. DURING THE 22-MINUTE TREATMENT, THE PADDLE LEAKED ALL OVER PATIENT, INCLUDING INTO THEIR GENITALIA AND BILATERAL UPPER LEG. THE PATIENT EXPERIENCED REDNESS ON THE ABDOMEN POST TREATMENT THAT WORSENED AFTER A FEW MINUTES. HEALTHCARE PROFESSIONAL IS CONSIDERING SENDING THE PATIENT TO THE EMERGENCY ROOM. HEALTHCARE PROFESSIONAL LATER REPORTED "THE CUSTOMER'S SKIN BECAME RED AFTER THE LEAK WAS NOTICED, POISON CONTROL NOTIFIED, SENT TO THE EMERGENCY DEPARTMENT AS RECOMMENDED BY POISON CONTROL".

  Patient problems: Caustic/Chemical Burns

  MAUDE report 24649985 ↗
• InjuryMar 13, 2026Leak/Splash

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED A COOLTONE TREATMENT ON (B)(6) 2026 USING THE COOLTONE APPLICATOR ON THE ABDOMEN AREA. DURING THE 22-MINUTE TREATMENT, THE PADDLE LEAKED ALL OVER PATIENT, INCLUDING INTO THEIR GENITALIA AND BILATERAL UPPER LEG. THE PATIENT EXPERIENCED REDNESS ON THE ABDOMEN POST TREATMENT THAT WORSENED AFTER A FEW MINUTES. HEALTHCARE PROFESSIONAL IS CONSIDERING SENDING THE PATIENT TO THE EMERGENCY ROOM. HEALTHCARE PROFESSIONAL LATER REPORTED "THE CUSTOMER'S SKIN BECAME RED AFTER THE LEAK WAS NOTICED, POISON CONTROL NOTIFIED, SENT TO THE EMERGENCY DEPARTMENT AS RECOMMENDED BY POISON CONTROL".

  Patient problems: Caustic/Chemical Burns

  MAUDE report 24591093 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT RECEIVED A COOTONE TREATMENT TO THE ABDOMEN AND PRESENTED WITH A "BURN" POST TREATMENT. NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING ANY TREATMENT OR MEDICAL INTERVENTION REQUIRED FOR THE REPORTED EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. DISTRIBUTOR TRIED TO CONTACT HEALTHCARE PROVIDER TO COLLECT MORE INFORMATION WITHOUT RESULT. SO, CIRCUMSTANCES AND DEGREE OF BURN UNKNOWN.

  Patient problems: Burn(s)

  MAUDE report 23864498 ↗
• InjuryNov 6, 2025Crack; Overheating of Device; Crack; Overheating of Device

  ALLERGAN AESTHETICS RECEIVED A REPORT OF A PATIENT TREATED ABDOMEN ON (B)(6)2025 USING THE COOLTONE APPLICATOR AND PRESENTED WITH BLANCHING/REDNESS IMMEDIATELY AFTER TREATMENT AND THEN THE PATIENT PRESENTED WITH BLISTER. PRACTICE BELIEVES 2ND-3RD DEGREE BURN. LATER PROVIDER REPORTED OVERHEATING APPLICATOR AND "APPLICATOR IS WARPED, CRACKED, AND BULGING OUT". APPLICATOR WAS REPLACED. DEVICE REMAINS AT THE USER FACILITY.TEE REPORT WAS FORWARDED TO MANUFACTURER ZIMMER MEDIZINSYSTEME GMBH.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 23486787 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN AESTHETICS RECEIVED A REPORT FROM A PATIENT WHO RECEIVED COOLTONE TREATMENT IN (B)(6) 2024, AND HAD SEVERE PAIN IN THE RIGHT THIGH AND STOPPED TREATMENT. REPORTER INDICATED THAT THE PATIENT WENT TO SEE A SPORTS MEDICINE DOCTOR AND WAS DIAGNOSED WITH TENDON TEAR FROM BONE. IT WAS REPORTED THAT THE PATIENT LOST ALL THE MUSCLE IN THE THIGHS AND BUTTOCKS BECAUSE OF THIS. THOUGH REQUESTED, ADDITIONAL EVENT INFORMATION WAS NOT PROVIDED BY THE PATIENT. ZIMMER MEDIZINSYSTEME GMBH WAS INFORMED BY ALLERGANAESTHETICS ON THIS EVENT.

  Patient problems: Rupture

  MAUDE report 23378729 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ABBVIE RECEIVED A REPORT ON 5/31/2023 ((B)(4)): A PROVIDER REPORTED TO ALLERGAN THAT A PATIENT RECEIVED A COOLTONE TREATMENT TO THE ABDOMEN ON (B)(6) 2023 AND PRESENTED WITH "STRONG ABDOMINAL CONTRACTIONS THAT SUCKED HER [PLASTIC SKYLA] IUD UP FURTHER INTO HER UTERUS". THE PATIENT WAS IN EXTREME PAIN AND ENDED UP GOING TO THE ER TO HAVE IT REPOSITIONED" 1 DAY POST TREATMENT.

  Patient problems: Abdominal Pain

  MAUDE report 21662846 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLERGAN RECEIVED REPORT THAT A FEMALE PATIENT WAS TREATED TO THE ABDOMEN WITH COOLTONE ON (B)(6) 2020. THE TREATMENT PROVIDER STATED THAT A COVER WAS USED OVER THE APPLICATOR BEFORE IT WAS PLACED OVER THE PATIENT'S SKIN. ON THE FOLLOWING DAY THE PATIENT DEVELOPED HIVES ON THE TREATED AREA THAT HAD LATER SPREAD THROUGHOUT HER BODY. ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED DUE TO HIVES IN THE VAGINAL AND ORAL MUCOSA AND DIFFICULTY BREATHING. THE PATIENT WAS GIVEN ORAL (B)(6) AND WAS DISCHARGED ON (B)(6) 2020. THE PATIENT WAS ADVISED BY HER PHYSICIAN THAT THE FORMATION OF HIVES MAY HAVE BEEN CAUSED BY OVERSTIMULATION AFTER PROLONGED PERIODS OF NO EXERCISE.

  Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Urticaria; Wheal(s)

  MAUDE report 9954560 ↗
• InjuryApr 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLERGAN RECEIVED PROVIDER REPORT THAT ON (B)(6) 2020 A PATIENT WAS BEING TREATED WITH COOLTONE AND THE DEVICE SHUT DOWN MID TREATMENT. THE TREATMENT PROVIDER EXPERIENCED AN ELECTRIC SHOCK WHEN THEY ATTEMPTED TO POWER THE MACHINE BACK ON. THE TREATMENT PROVIDER THEN ATTEMPTED TO UNPLUG THE DEVICE AND EXPERIENCED AN ELECTRIC SHOCK UP THEIR ARM.

  Patient problems: Electric Shock

  MAUDE report 9918533 ↗
• InjuryMar 25, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2020 ALLERGAN RECEIVED A REPORT REGARDING A PATIENT WHO SUSTAINED AN ABDOMINAL BURN FROM A METAL BUTTON ON CLOTHING WORN DURING 2-MINUTE COOLTONE TREATMENTS TO BOTH ABDOMEN AND BUTTOCKS. PRIOR TO THE COOLTONE TREATMENT, THE PATIENT WAS ALSO TREATED WITH A 5-MINUTE SESSION USING EMSCULPT, A NON-ALLERGAN PRODUCT. IT WAS STATED THAT THE PATIENT'S ABDOMINAL TREATMENT AREA HAD DECREASED SENSATION DUE TO PRIOR ABDOMINOPLASTY. THE BURN WAS DIAGNOSED AS 3RD DEGREE AND IS HEALING WELL FOLLOWING DEBRIDEMENT AND TOPICAL ANTIBIOTICS, CORTICOSTEROIDS, AND SCAR-MINIMIZATION OINTMENTS. THE COOLTONE USER MANUAL STATES THAT METALLIC OBJECTS SHOULD BE AT LEAST 1.2 METERS AWAY FROM THE DEVICE AND ITS ACCESSORIES DURING USE. ALLERGAN IS IN CONTACT WITH THE TREATMENT PROVIDER IN ORDER TO OBTAIN ADDITIONAL FOLLOW-UP INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE RE-ASSESSED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED. BASED ON THE INFORMATION CURRENTLY AVAILABLE TO THE DEVICE IMPORTER, ZELTIQ AESTHETICS (ALLERGAN), A SERIOUS INJURY POSSIBLY CAUSED BY USE ERROR HAS OCCURRED DURING COOLTONE TREATMENT. AN INITIAL 30-DAY MDR WAS SUBMITTED BY ALLERGAN TO THE FDA ON 06-MAR-2020,

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 9881201 ↗