Cellfina System Disposable Tray CK1 Rev KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840763100612), received between May 1, 2018 and May 1, 2018 — 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.

• InjuryMay 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 06-APR-2018 A MERZ AFFILIATE IN (B)(6) BECAME AWARE OF A PATIENT REPORTED TO HAVE DEVELOPED AN INFECTION POST-CELLFINA TREATMENT. THE TREATMENT DATE WAS REPORTED AS (B)(6) 2018 AND THE PATIENT REPORTED THE INFECTION ON (B)(6) 2018. THE PATIENT HAD REPORTEDLY "PLAYED SOCCER [A FEW] DAYS AFTER THE TREATMENT." THE PHYSICIAN PRESCRIBED ANTIBIOTICS ON (B)(6) 2018; HOWEVER, NO IMPROVEMENT WAS REPORTED. ON (B)(6) 2018 A LOCAL ANTIBIOTIC GEL WAS APPLIED, FOLLOWED BY A RINSING OF THE INFECTION ON (B)(6) 2018. A SMEAR OF THE INFECTION SITE WAS TAKEN ON (B)(6) 2018. THE INFECTION WAS "SCRAPED OUT" ON (B)(6) 2018 AND A REDUCTION OF THE INFECTION WAS REPORTED. SUBSEQUENT TO THESE ACTIONS, IT WAS REPORTED THE PATIENT HAS A "DIMPLE AFTER THE SCRAPING (LOSS OF TISSUE VOLUME)."

  Patient problems: Unspecified Infection

  MAUDE report 7477015 ↗

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