Celt ACD Vascular Closure Device 7F KCLT-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05391530280129), received between Sep 5, 2023 and Apr 17, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2025Migration; Migration

  IT WAS REPORTED THAT A 7F CELT ACD DEVICE WAS DEPLOYED AT THE END OF THE PROCEDURE. UPON EJECTION THE IMPLANT MIGRATED TO THE POPLITEAL ARTERY. PATIENT WAS TAKEN TO THE SURGERY AND THE IMPLANT WAS REMOVED. PATIENT WAS REPORTED TO HAVE NO COMPLICATIONS AFTER PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21855062 ↗
• InjurySep 5, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT WHILE ATTEMPTING TO DEPLOY THE PROXIMAL WING THE PHYSICIAN NOTICED THAT THE DEVICE FELT AS IF IT PULLED THROUGH THE ARTERIAL WALL. IT APPEARS THAT PHYSICIAN EJECTED THE IMPLANT FROM THE DELIVERY SYSTEM AT THIS POINT AS THE IMPLANT IS REPORTED TO BE IN THE SOFT TISSUE UNDER THE SKIN. THE PROCEDURE WAS COMPLETED AND MANUAL PRESSURE HELD FOR 10 MINUTES. 3 DAYS LATER THE PATIENT WAS BROUGHT BACK TO THE FACILITY WITH SYMPTOMS OF PSEUDOANEURYSM. THE PHYSICIAN USED A THROMBIN INJECTION TO TREAT THE PSEUDOANEURYSM. THERE WAS NO FURTHER INCIDENT AND TO OUR KNOWLEDGE THE PATIENT IS NOW WELL. ON A FURTHER UPDATE IMPLANT WAS OBSERVED TO BE AWAY FROM THE ARTERIAL WALL IN THE TISSUE TRACT.

  Patient problems: Pseudoaneurysm

  MAUDE report 17681064 ↗