AESCULAP FE908KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04038653385966), received between Dec 28, 2023 and Dec 28, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Failure to Seal” (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. How this data works · Data updated Oct 13, 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 28, 2023Failure to Seal; Failure to Seal

  IT WAS REPORTED TO AESCULAP INC. THAT AN PHYNOX AVM CLIP APP FCPS TUB SHAFT90MM (PART# FE908K) WAS USED DURING A PROCEDURE ON DECEMBER 11 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. 400634274 (2916714-2023-00143) 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409070 ↗