Celt ACD Vascular Closure Device 5F KCLT-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05391530280006), received between Nov 16, 2021 and Jan 13, 2025 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Difficult to Insert; Difficult to Advance; Difficult to Insert; Difficult to Advance

  IT WAS REPORTED THAT A 5F CELT DEVICE WAS ATTEMPTED TO BE ADVANCED INTO A 5F CORDIS AVANTI SHEATH AT THE END OF THE PROCEDURE. IT MET RESISTANCE UPON INTRODUCTION TO THE 5F SHEATH AND IT WOULD NOT ADVANCE TO FULLY ENGAGE. THE CELT DEVICE WAS WITHDRAWN AND THE GROIN WAS MANAGED WITH MANUAL COMPRESSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137398 ↗
• MalfunctionJul 30, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ON MULTIPLE OCCASIONS TO INSERT 5F CELT DEVICES INTO 5F CORDIS AVANTI SHEATHS. IN EACH SITUATION, THE PHYSICIAN REPORTED EXPERIENCING EXCESSIVE RESISTANCE DURING INSERTION AND WAS UNABLE TO ADVANCE THE DELIVERY SYSTEM COMPLETELY INTO THE SHEATH. IN EACH SITUATION, A NEW 5F CELT WAS USED WITH A DIFFERENT LOT NUMBER AND THE CLOSURE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. DEVICES ARE BEING RETURNED TO VASORUM LTD FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19859552 ↗
• MalfunctionJul 30, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED ON 6 OCCASIONS TO INSERT 5F CELT DEVICES INTO 5F CORDIS AVANTI SHEATHS. IN EACH SITUATION, THE PHYSICIAN REPORTED EXPERIENCING EXCESSIVE RESISTANCE DURING INSERTION AND WAS UNABLE TO ADVANCE THE DELIVERY SYSTEM COMPLETELY INTO THE SHEATH. IN EACH SITUATION, A NEW 5F CELT WAS USED WITH A DIFFERENT LOT NUMBER AND THE CLOSURE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. DEVICES HAVE BEEN RETURNED TO VASORUM LTD FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19859529 ↗
• InjuryJan 18, 2024Migration; Migration

  THE FOLLOWING IS AS REPORTED IN MW5148762: NEW ARTERIAL CLOSURE DEVICE USED POST PROCEDURE TO CLOSE RIGHT FEMORAL ARTERIOTOMY. IT APPEARS ALL DEPLOYMENT STEPS WERE FOLLOWED CORRECTLY BUT DEVICE DID NOT FULLY DEPLOY. DUE TO INCOMPLETE DEPLOYMENT, DEVICE MIGRATED DOWN RIGHT LEG ARTERIAL SYSTEM. DEVICE IS NON-OCCLUSIVE. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18532791 ↗
• InjuryDec 16, 2022Migration; Migration

  IT WAS REPORTED THAT A PHYSICIAN ATTEMPTED TO USE A CELT ACD 5F TO CLOSE A 5F ARTERIAL PUNCTURE. STEPS WERE PERFORMED AS PER IFU BUT BLEEDING WAS NOTICED IMMEDIATELY UPON EJECTION OF THE IMPLANT. MANUAL COMPRESSION WAS PERFORMED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN THEN ELECTED TO REACCESS THE ARTERIAL SYSTEM FROM THE OPPOSITE GROIN TO DETERMINE IF THE IMPLANT HAD EMBOLIZED AND IF SO WHAT LOCATION. THE ANGIOGRAM REVEALED THE IMPLANT IN THE MIDDLE OF THE PERONEAL ARTERY BUT WAS NOT OCCLUSIVE AND THE PATIENT HAD NO SYMPTOMS. THE PATIENT WAS HELD FOR OBSERVATION OVERNIGHT AND A VASCULAR SURGEON WAS CONSULTED. IT IS NOT KNOWN IF THE PATIENT DEVELOPED ANY SYMPTOMS THE FOLLOWING DAY BUT IT IS UNDERSTOOD THE SURGEON ELECTED TO PERFORM SURGERY TO REMOVE THE IMPLANT. IT IS NOT KNOWN WHAT SURGERY WAS PERFORMED SPECIFICALLY BUT IT IS UNDERSTOOD THAT THE PERONEAL ARTERY WAS SACRIFICED DURING THE SURGERY. THE PATIENT WAS REPORTED TO BE STABLE AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Foreign Body Embolism

  MAUDE report 15993944 ↗
• InjuryDec 7, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT PHYSICIAN ATTEMPTED TO USE A 5F CELT TO CLOSE A 5F ARTERIAL ACCESS PUNCTURE. THE PHYSICAN NOTED THAT WHEN HE ATTEMPTED TO DEPLOY THE DISTAL WING, THE HANDLE DID NOT FULLY POP BACK. AN ULTRASOUND WAS PERFORMED WHICH REVEALED THAT THE DISTAL WINGS DID NOT FULLY OPEN. THE SHEATH AND THE DELIVERY SYSTEM WITH THE IMPLANT ATTACHED WERE REMOVED FROM THE PATIENT AND MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PATIENT HAD NO COMPLICATIONS AND WAS DISCHARGED THE SAME DAY. NO IMPLANT REMAINED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15930981 ↗
• InjuryNov 9, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DR ATTEMPTED TO CLOSE WITH A 5F SHEATH USING A 5F CELT ACD DEVICE. DURING THE EJECTION STEP THE DEVICE FAILED TO EJECT THE IMPLANT. THE TWO WINGS OF THE IMPLANT WERE CORRECTLY DEPLOYED. IN ORDER TO DEAL WITH THE SITUATION, THE DOCTOR THEN DECIDED TO PULL THE IMPLANT OUT OF THE PATIENT WHILE STILL ATTACHED TO THE DELIVERY SYSTEM. DR THEN HELD MANUAL PRESSURE TO ACHIEVE HAEMOSTASIS. THE PATIENT DEVELOPED A HAEMATOMA WHICH WAS DISCOVERED IN THE POST OPERATIVE CARE AREA AND THIS WAS MANAGED WITH MORE MANUAL PRESSURE. THE PATIENT WAS SUBSEQUENTLY DISCHARGED ON THE SAME DAY WITHOUT FURTHER INCIDENT.

  Patient problems: Hematoma

  MAUDE report 15757795 ↗
• InjuryDec 22, 2021Failure to Eject; Failure to Eject

  A CELT 5F DEVICE WAS USED TO ATTEMPT TO CLOSE A 5F ARTERIAL PUNCTURE. DURING THE DEPLOYMENT OF THE PROXIMAL WING IT WAS NOTED THAT AFTER SEVERAL TURNS THE PROXIMAL WING DID NOT APPEAR TO OPEN. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE TO LAST STEP OF EJECTING THE IMPLANT. HE WAS UNABLE TO EJECT THE IMPLANT, SO HE ELECTED TO INSTEAD ABORT BY PULLING OUT THE ENTIRE DELIVERY SYSTEM (INCLUDING THE IMPLANT STILL ATTACHED) AND USED MANUAL COMPRESSION TO ACHIEVE HEMOSTASIS. THE PATIENT WAS DISCHARGED THE SAME DAY WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13063861 ↗
• InjuryDec 14, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT PHYSICIAN ATTEMPTED TO CLOSE A 5F SHEATH WITH THE 5F CELT DEVICE. UPON EJECTION OF THE IMPLANT BLEEDING WAS NOTED AND MANUAL COMPRESSION WAS APPLIED. THE PHYSICIAN CHOSE TO IMMEDIATELY XRAY AND DISCOVERED THE IMPLANT WAS IN THE SUPERFICIAL FEMORAL ARTERY. PULSES WERE CHECKED AND THEY WERE GOOD. THE PATIENT SHOWED NO SIGNS OF ISCHEMIA AND WAS DISCHARGED THE SAME DAY WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12999164 ↗
• InjuryNov 16, 2021Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE INCIDENT OCCURRED WHEN THE USER WAS USING A 5F CELT CLOSURE DEVICE. UPON ATTEMPTING TO OPEN THE PROXIMAL WINGS AFTER CORRECTLY LOCATING THE DISTAL WING AT THE PUNCTURE SITE, THE USER WAS UNABLE TO OPEN THE PROXIMAL WING DESPITE TURNING THE HANDLE SEVERAL TURNS. ALTHOUGH THE PROXIMAL WING HAD NOT OPENED, THE USER ATTEMPTED TO EJECT THE IMPLANT FROM THE DEVICE WITHOUT SUCCESS. THE USER DECIDED TO PULL THE WHOLE SYSTEM OUT OF THE PUNCTURE SITE AND APPLIED MANUAL COMPRESSION. THE PATIENT WAS DISCHARGED WITHOUT ANY COMPLICATIONS. THE DEVICE WAS RETURNED TO VASORUM LTD FOR EXAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820081 ↗