Cellfina System Disposable Procedure Kit Rev ORecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840763100827), received between May 3, 2019 and Sep 30, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K161885); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PRACTICE REPORTED TO MERZ VIA EMAIL ON (B)(6) 2021 INFORMATION REGARDING AN ALLEGED CELLFINA ADVERSE EVENT. ACCORDING TO THE REPORT: "I HAVE A PATIENT THAT DID NOT RESPOND TO CELLFINA AS WE TYPICALLY SEE... THE PATIENT IS HAVING SOME EXTRA SWELLING WE DON'T NORMALLY SEE AND WE ARE NOW FOUR MONTHS OUT FROM TREATMENT. IT IS NOT AN INJURY, IT IS PERSISTENT RAISED LUMPS. THEY HAVE BEEN PRESENT SINCE THE TREATMENT, VISIBLE WHEN I SAW HER FOR A FOLLOW UP AT ONE MONTH AND STILL PRESENT." THIS PATIENT WAS TREATED ON WITH CELLFINA ON THE BUTTOCKS AND THIGHS. NO PRIOR TREATMENTS WITH CELLFINA OR OTHER PROCEDURES IN THE AFFECTED AREA. ANESTHESIA: 1,100CC OF TUMESCENT WERE USED (1,250 CC LR, 57 CC 1% LIDOCAINE, 1.25 CC EPINEPHRINE). PATIENT'S BMI AT TIME OF TREATMENT: 24.3. 55 TOTAL RELEASES WERE PERFORMED USING A NARROW RELEASE. MOST RELEASES WERE AT A DEPTH OF 6MM, A FEW WERE PERFORMED AT 10MM. THE PRACTICE STATED NO MALFUNCTIONS OCCURRED DURING TREATMENT AND THE DEVICES PERFORMED AS INTENDED. DURING FOLLOW UP FOR THIS INITIAL REPORT, THE PRACTICE STATED THE CELLULITE HAS IMPROVED AND THERE WAS IMPROVEMENT IN THE LUMPS BETWEEN ONE AND FOUR MONTHS AND DID NOT CONSIDER THIS AN INJURY. NO INT

  Patient problems: Bruise/Contusion; Deformity/ Disfigurement; Swelling/ Edema

  MAUDE report 15512172 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TREATING PHYSICIAN REPORTED THERE HAS BEEN NO SIGNIFICANT CHANGE IN THE PATIENT'S CONDITION AND THE SCARS ARE SLIGHTLY LIGHTENING VIA HQRA TREATMENTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain; Scar Tissue; Scarring; Skin Discoloration

  MAUDE report 8822589 ↗
• MalfunctionMay 3, 2019Break; Break

  A CUSTOMER REPORTED ON (B)(6) 2019 THAT THE BLADE IN TWO CELLFINA DISPOSABLE KITS BROKE ABOUT A MINUTE INTO THE PROCEDURE. THIS IS REPORT TWO OF TWO. THE BLADE DID NOT BREAK WHILE INSERTED INTO THE PATIENT AND THERE WAS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579557 ↗
• MalfunctionMay 3, 2019Break; Break

  A CUSTOMER REPORTED ON (B)(6) 2019 THAT THE BLADE IN TWO CELLFINA DISPOSABLE KITS BROKE ABOUT A MINUTE INTO THE PROCEDURE. THIS IS REPORT ONE OF TWO. THE BLADE DID NOT BREAK WHILE INSERTED INTO THE PATIENT AND THERE WAS NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579556 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161885. One submission often covers many models, so check the product and lot details in each record.

• Z-0749-2017 · Nov 14, 2016 · Terminated
  Cellfina Prep Pack, Part No. CP1