AESCULAP FE963KRecalls & reported problems
Aesculap AG · AVM MICROCLIP PHYNOX CVD.3MM STERILE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964381744), received between Dec 28, 2023 and Dec 28, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Failure to Seal” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Seal3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
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.3MM STERILE (PART# FE963K) 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 18409060 ↗InjuryDec 28, 2023Failure to Seal; Failure to Seal
IT WAS REPORTED TO AESCULAP INC. THAT AN AVM MICROCLIP PHYNOX CVD.3MM STERILE (PART# FE963K) 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 18409055 ↗InjuryDec 28, 2023Failure to Seal; Failure to Seal
IT WAS REPORTED TO AESCULAP INC. THAT AN AVM MICROCLIP PHYNOX CVD.3MM STERILE (PART# FE963K) 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 18409052 ↗
Other CLIP, ANEURYSM devices
- LAZIC 45.872Peter Lazic GmbH · Clip, Aneurysm1 recall0 reports
- LAZIC S.45.872Peter Lazic GmbH · Clip, Aneurysm1 recall0 reports
- AESCULAP FE964KAesculap AG · CLIP, ANEURYSM3 reports
- Medicon 58.60.08Medicon eG. Chirurgiemechaniker-Genossenschaft · CLIP, ANEURYSM2 reports
- AESCULAP FT780DAesculap AG · CLIP, ANEURYSM2 reports
- AESCULAP FT599TAesculap AG · CLIP, ANEURYSM1 report
- LAZIC S.35.714Peter Lazic GmbH · Clip, Aneurysm1 report
- AESCULAP FE953KAesculap AG · CLIP, ANEURYSM1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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