Cellfina CK1-EU Rev ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840763100537), received between Mar 2, 2017 and Jun 26, 2018 — classified as 1 injury, 2 malfunctions.

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

• MalfunctionJun 26, 2018Break; Break

  A (B)(6) AFFILIATE FROM (B)(6) RECEIVED A REPORT ON (B)(6) 2018 REGARDING A CELLFINA BLADE. IT WAS REPORTED THAT AFTER 25 RELEASES, THE BLADE BROKE. THE AFFILIATE STATED THAT THERE WERE NO DISADVANTAGES FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7640073 ↗
• MalfunctionMar 26, 2018Physical Property Issue; Appropriate Device Problem Term/Code Not Available; Physical Property Issue; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2018, THE MERZ AFFILIATE IN (B)(4) WAS MADE AWARE OF A PRODUCT PROBLEM THAT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE BLADE FROM A CELLFINA DISPOSABLE KIT BROKE DURING A TREATMENT REQUIRING RETRIEVAL. NO ADDITIONAL LOCAL ANAESTHETIC WAS ADMINISTERED NOR WERE SUTURES REQUIRED TO CLOSE THE RETRIEVAL POINT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7370565 ↗
• InjuryMar 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CELLFINA PROCEDURE, THE PHYSICIAN HAD TO INCREASE THE PRESSURE OF THE VACUUM IN ORDER TO HAVE A GOOD VACUUM ASSISTED TISSUE CAPTURE USING THE VACUUM HANDPIECE. DURING A SUBCUTANEOUS TISSUE RELEASE WITH THE MOTOR MODULE SWITCHED ON, THE VACUUM PRESSURE WAS LOST, RESULTING IN A 2-3 CM LACERATION OF THE PATIENTS SKIN. THE PHYSICIAN SPECULATES THE IMMEDIATE VACUUM PRESSURE LOSS WAS DUE TO: NUMEROUS STABS THROUGH THE ELASTOMERIC SEPTUM OF THE VACUUM HANDPIECE MAY HAD CAUSED A HOLE/DISRUPTION IN THE SEPTUM THAT LET AIR THROUGH; SKIN SURFACE TOO WET; ACCIDENTAL SWITCHING OFF OF THE VACUUM FOOT PEDAL. THE PHYSICIAN STATED THAT PERSON OPERATING THE VACUUM FOOT PEDAL WAS NOT A MEDICAL PROFESSIONAL, AND MAY HAVE BUMPED THE PEDAL.

  Patient problems: Laceration(s)

  MAUDE report 6374664 ↗