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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05391530280679), received between May 22, 2025 and Jun 11, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryJun 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A MEDWATCH REPORT FORM WAS RECEIVED WHICH STATED THAT THE 6F CELT ACD CLOSURE DEVICE WAS MAL-DEPLOYED AND INTRALUMINAL IN THE RIGHT COMMON FEMORAL ARTERY. THE MAL-DEPLOYED CLOSURE DEVICE WAS IMMEDIATELY RETRIEVED SUCCESSFULLY. AN UPDATE WAS RECEIVED ON (B)(6) 2025 INFORMING THAT THE EMBOLIZED IMPLANT WAS RETRIEVED SUCCESSFULLY BY A SNARE. ATTEMPTS TO OBTAIN FINAL PATIENT STATUS WERE UNSUCCESSFUL.

  Patient problems: Insufficient Information

  MAUDE report 22183532 ↗
• InjuryMay 22, 2025Off-Label Use; Malposition of Device; Off-Label Use; Malposition of Device

  IT WAS REPORTED THAT PHYSICIAN USED A 7F CELT ACD PLUS DEVICE TO CLOSE AN 8F ARTERIOTOMY AFTER A 4-HOUR CORONARY CTO PROCEDURE. THE DEVICE WAS RETRACTED TO WHAT WAS THOUGHT TO BE THE ARTERIOTOMY AFTER THE DISTAL WING WAS DEPLOYED. UPON RAISING TO 90 DEGREES THE BLOOD SIGNAL DID NOT COMPLETELY STOP SO PHYSICIAN MADE MULTIPLE ATTEMPTS TO RETRACT FURTHER AND ELEVATE AGAIN. THE BLOOD SIGNAL APPEARED TO STOP. UPON DEPLOYMENT OF THE PROXIMAL WING THE DEVICE APPEARED TO JUMP UPWARD SLIGHTLY. IMPLANT WAS EJECTED, BLEEDING WAS NOTED AND MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS FOR APPROXIMATELY 1 HOUR. THE PHYSICIAN ELECTED TO GIVE A BLOOD TRANSFUSION SINCE THE PATIENT WAS BECOMING HYPOTENSIVE, AND THE PATIENT WAS THEN REASSESSED AND AN ATTEMPT TO ACHIEVE HAEMOSTATIC CONTROL WITH AN ANGIOPLASTY BALLOON WAS NOT SUCCESSFUL. PATIENT WAS THEN BROUGHT TO SURGERY TO REPAIR THE ARTERIOTOMY. PATIENT WAS REPORTED TO BE OK AND SURGERY SUCCESSFUL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22068514 ↗