AESCULAP FE964KRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964381751), received between Jun 7, 2021 and Dec 28, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Seal” (2 reports).

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. How this data works · Data updated Oct 13, 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.

• InjuryDec 28, 2023Failure to Seal; Failure to Seal

  IT WAS REPORTED TO AESCULAP INC. THAT AN AVM MICROCLIP PHYNOX CVD.4MM STERILE (PART# FE964K) WAS USED DURING A PROCEDURE ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE CLIPS WERE STAYING OPEN AFTER BEING LOADED INTO THE PATIENT. REPORTEDLY THE PATIENT WAS RETURNED TO THE OPERATING ROOM AFTER THE PROCEDURE AND 3 MORE CLIPS WERE IMPLANTED FOR THE SECOND TIME. THERE WERE SEVEN ATTEMPTS AT IMPLANTING IN TOTAL WHERE THE CLIPS WERE STAYING OPEN. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409065 ↗
• InjuryDec 28, 2023Failure to Seal; Failure to Seal

  IT WAS REPORTED TO AESCULAP INC. THAT AN AVM MICROCLIP PHYNOX CVD.4MM STERILE (PART# FE964K) WAS USED DURING A PROCEDURE ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE CLIPS WERE STAYING OPEN AFTER BEING LOADED INTO THE PATIENT. REPORTEDLY THE PATIENT WAS RETURNED TO THE OPERATING ROOM AFTER THE PROCEDURE AND 3 MORE CLIPS WERE IMPLANTED FOR THE SECOND TIME. THERE WERE SEVEN ATTEMPTS AT IMPLANTING IN TOTAL WHERE THE CLIPS WERE STAYING OPEN. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE XC (B)(4). 400634273 (2916714-2023-00142) FE964K 400634275 (2916714-2023-00144) FE963K 400634276 (2916714-2023-00145) FE963K 400634277 (2916714-2023-00146) FE962K 400634278 (2916714-2023-00147) FE963K. 400634279 (2916714-2023-00148) FE953K. 400634280 (2916714-2023-00149) FE908K.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409050 ↗
• MalfunctionJun 7, 2021Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FE964K - AVM MICROCLIP PHYNOX CVD.4MM STERILE. ACCORDING TO THE COMPLAINT DESCRIPTION, DURING AN ARTERIOVENOUS MALFORMATION (AVM) PROCEDURE, TWO OF THE AVM MICROCLIPS MALFUNCTIONED. THEY DID NOT "CLOSE DOWN TIGHT" AS EXPECTED. THE SCRUB TECH LOADED THE CLIPS IN THE APPLIER, BUT TWO OF THE CLIPS WOULD NOT CLOSE AFTER LOADING. IT WAS CONFIRMED THAT THE APPLIER WAS USED TO SUCCESSFULLY SECURE OTHER CLIPS BEFORE AND AFTER THE TWO FAILURES. AS THE TWO MICRO CLIPS WERE IN THE OPEN POSITION, THEY WERE EASILY REMOVED FROM THE PATIENT WITHOUT ANY HARM OR ADDITIONAL MEDICAL INTERVENTION. IT WAS EXPLAINED THAT THE CLIPS WERE KIND OF JUST FLOATING IN THE AREA AND NOT REALLY ATTACHED TO THE PATIENT'S VESSEL. AS SUCH THE DEVICES WERE EASILY REPLACED WITH ADDITIONAL CLIPS AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947862 ↗