Cellfina System Disposable Tray CK1 Rev JRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840763100414), received between Dec 2, 2021 and Dec 2, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN PHONED MERZ/ULTHERA ON (B)(6) 2020 AND STATED THAT HE TREATED A PATIENT WITH CELLFINA APPROXIMATELY TWO YEARS AGO, AND THE PATIENT ALLEGED TO HAVE OUT-POUCHING OF TISSUE THROUGHOUT THE BUTTOCKS. NO PAIN WAS REPORTED. DURING FOLLOW UP WITH THE PHYSICIAN ON (B)(6) 2020, HE STATED THE PATIENT WAS TREATED TWICE (B)(6) 2018 AND (B)(6) 2018 ON THE BUTTOCKS AND POSTERIOR THIGHS. IMMEDIATELY FOLLOWING TREATMENT, THE PATIENT EXPERIENCED "SOME EXPECTED HEMATOMA FORMATION (PER PATIENT AS SHE DID NOT RETURN TO CLINIC FOR PHOTOS LIKE AFTER FIRST TREATMENT DESPITE RECOMMENDED HER TO) AND DURING THE PATIENT'S MOST RECENT FOLLOW UP APPOINTMENT HE OBSERVED "ANETODERMA LIKE OUT-POUCHING IN SOME OF THE TREATED AREAS." THE PATIENT IS REPORTEDLY UNDERGOING VENUS FREEZE TREATMENTS TO RESOLVE THE ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Deformity/ Disfigurement; Hematoma

  MAUDE report 12917661 ↗

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