CoolSculpting Upper Module BRZ-CG1-UMD-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816417020018), received between Dec 10, 2018 and Apr 14, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  ABBVIE RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT WAS TREATED USING THE COOLADVANTAGE APPLICATOR AND PRESENTED WITH PARADOXICAL HYPERPLASIA (PH).

  Patient problems: Hyperplasia

  MAUDE report 24874927 ↗
• InjuryJan 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 02/15/2017 ALLERGAN RECEIVED REPORT OF A (B)(6) FEMALE PATIENT WHO HAD DEVELOPED BILATERAL AND SYMMETRICAL LARGE, HARD, TENDER, WARM AND ERYTHEMATOUS PLAQUES ON THE TREATED AREAS 2 WEEKS AFTER RECEIVING COOLSCULTPING TREATMENT ON BILATERAL INNER THIGHS ON (B)(6) 2017. THE PATIENT WAS INITIALLY DIAGNOSED WITH CELLULITIS AND WAS GIVEN KEFLEX AND PREDNISONE, WITH NO IMPROVEMENT OF SYMPTOMS. ON (B)(6) 2017 THE PHYSICIAN CONFIRMED THAT THE PATIENT HAD COMPLETED A COURSE OF STEROIDS, AND THE SYMPTOMS HAVE RESOLVED. ON (B)(6) 2017, THE PATIENT CONSULTED HER PHYSICIAN BECAUSE THE SAME AREA HAD TURNED INTO DARKENED, HARDENED BALLS, WARM AND TENDER TO TOUCH. ON (B)(6) 2017, ALLERGAN WAS MADE AWARE THAT THE PHYSICIAN PROVIDED A DIAGNOSIS OF FAT NECROSIS CAUSED BY COLD-INDUCED PANNICULITIS, AND STATED THAT SURGICAL INTERVENTION WAS NEEDED TO REMOVE THE UNDERLYING CALCIFIED FATS. ON (B)(6) 2017 THE PRACTICE CONFIRMED THAT THE PATIENT HAD COMPLETED SURGERY, AND HAS REFUSED TO PROVIDE FURTHER INFORMATION. ON (B)(6) 2017 THE SYSTEM LOG REVIEW WAS COMPLETED AND NO DEVICE MALFUNCTION HAD BEEN IDENTIFIED. THE RESULT OF THE DEVICE "INVESTIFGATION" SHOWED THAT THE DEVICE FUNCTIONED AS DESIGNED.

  Patient problems: Necrosis

  MAUDE report 8254601 ↗
• InjuryDec 10, 2018Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 ALLERGAN WAS MADE AWARE OF A REPORT WHEREIN AN (B)(6) FEMALE PATIENT WHO RECEIVED 4 CYCLES OF COOLSCULPTING TREATMENT TO THE LOWER ABDOMEN USING A COOLADVANTAGE APPLICATOR NOTICED SWELLING ON THE UPPER PART OF HER LEFT LEG AT THREE WEEKS POST TREATMENT . WITHIN A FEW DAYS TO A WEEK, THE PATIENT NOTICED HER ENTIRE LEFT LEG HAD BECOME SWOLLEN, WHICH PROMPTED HER TO CONSULT HER PRIMARY CARE PHYSICIAN. THE PATIENT'S PHYSICIAN ADVISED HER TO GO TO THE ER WHERE ULTRASOUND WAS PERFORMED AND NO BLOOD CLOT WAS SEEN ON THE LEFT LEG. CT SCAN, ABDOMINAL SCOPE, COLONOSCOPY WERE PERFORMED, AND THE PHYSICIAN TOLD THE PATIENT THAT SHE HAD AN "UNPROVOKED BLOOD CLOT" IN THE LOWER ABDOMEN. THE PATIENT WAS ALSO TOLD THAT SHE HAD "EXTREMELY LOW HEMOGLOBIN LEVEL." THE PATIENT RECEIVED 3 IRON INFUSIONS AT THE HOSPITAL, AND WAS SUBSEQUENTLY PUT ON BLOOD THINNERS AND IRON SUPPLEMENTS. THE PATIENT HAD NO PRIOR HISTORY OF DEEP VEIN THROMBOSIS, ANEMIA OR ANY CIRCULATORY ISSUE. THERE WAS NO REPORTED OR SUSPECTED DEVICE MALFUNCTION. NO ERROR MESSAGE OCCURRED DURING TREATMENT, AND THE PATIENT COMPLETED THE COOLSCULPTING TREATMENT WITH NO ISSUE. HOWEVER, ACCORDING TO THE NURSE THE PATIENT WAS DUAL-

  Patient problems: Thrombosis; Thrombus

  MAUDE report 8148736 ↗