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AESCULAP FT780DRecalls & reported problems

Aesculap AG · YASARGIL TI PERM STD-CLIP STR 15MM · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653254804), received between Mar 10, 2021 and Mar 10, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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

Device problems

  • Loosening of Implant Not Related to Bone-Ingrowth2

Patient problems

  • Aneurysm2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 10, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00202 (B)(4), 9610612-2021-00209 (B)(4), 9610612-2021-00210 (B)(4), 9610612-2021-00201 (B)(4).

    Patient problems: Aneurysm

    MAUDE report 11455719 ↗
  • InjuryMar 10, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FT780D - YASARGIL TI PERM STD-CLIP STR 15MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CLIP WAS LOOSE AND DECOMPRESSED. THIS IS A SURVEY OF CLIPS REMOVED DURING RE-SURGERY OF PATIENTS WHO UNDERWENT SURGERY AT THE (B)(6) MEDICAL CENTER IN 2012. A NEW ANEURYSM DEVELOPED NEAR THE AREA WHERE THESE CLIPS WERE HUNG, AND REOPERATION WAS PERFORMED. DOCTORS SEEM TO SUSPECT THAT THE ANEURYSM MAY HAVE BEEN CAUSED BY THE REDUCED PRESSURE ON THE CLIP THAT WAS REMOVED. A REVISION SURGERY WAS NECESSARY. ADDITIONAL INFORMATION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED AS OF THIS REPORT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 9610612-2021-00202 (B)(4) + FT760T), 9610612-2021-00209 ((B)(4) + FT780D), 9610612-2021-00210 ((B)(4) + FT780D), 9610612-2021-00201 ((B)(4) + FT792D).

    Patient problems: Aneurysm

    MAUDE report 11455351 ↗

Other CLIP, ANEURYSM devices

All CLIP, ANEURYSM devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.