Celt ACD Vascular Closure Device 6F KCLT-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05391530280068), received between Oct 10, 2017 and Nov 27, 2025 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2025Use of Device Problem; Use of Device Problem

  THE FOLLOWING WAS REPORTED THROUGH MEDWATCH (MW5177699) "AFTER A LEFT HEART CATHETERIZATION, IT WAS DECIDED TO USE A CLOSURE DEVICE TO CLOSE THE FEMORAL ARTERIOTOMY. DURING DEPLOYMENT OF CELT 6F DEVICE, THE FOOTPLATE BROKE OFF AND EMBOLIZED DOWN THE LEG. REQUIRED VASCULAR SURGERY INTERVENTION TO REMOVE THE FOOTPLATE". FOLLOW UP INVESTIGATION INDICATED THE IMPANT WAS EMBOLIZED. SNARE RETRIEVAL WAS UNSUCCESSFUL. THE IMPLANT WAS SUCCESSFULLY REMOVED SURGICALLY. THE PATIENT WAS STABLE AFTER THE SURGERY AND DISCHARGED THE NEXT DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23665446 ↗
• InjuryFeb 12, 2025Migration; Migration

  IT WAS REPORTED THAT A 5F CELT DEVICE WAS USED TO CLOSED A 5F ARTERIAL PUNCTURE. UPON EJECTION OF THE IMPLANT IT WAS NOTED THAT THE CLOSURE DIDN'T WORK AND MANUAL COMPRESSION WAS APPLIED. DURING THE MANUAL COMPRESSION STEP, THE ATTENDING PHYSICIAN ELECTED TO RETRIEVE THE IMPLANT BY ACCESSING THE OPPOSITE GROIN TO GO UP AND OVER AND SNARE THE IMPLANT. THE PHYSICIAN WAS ABLE TO COMPLETE SNARING OF IMPLANT SUCCESSFULLY WITH NO ADVERSE EVENTS/COMPLICATIONS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21362097 ↗
• MalfunctionJan 13, 2025Difficult to Insert; Difficult to Advance; Difficult to Insert; Difficult to Advance

  IT WAS REPORTED THAT A 6F CELT DEVICE WAS ATTEMPTED TO USE FOLLOWING A DIAGNOSTIC ANGIOGRAPHY. IT WOULD NOT INTRODUCE CORRECTLY, MEETING RESISTANCE UPON INTRODUCTION TO THE 6F SHEATH AND SUBSEQUENTLY SHREDDED THE SHEATH AS IT WAS REMOVED. AN ATTEMPT WAS THEN MADE TO THEN USE A MYNX DEVICE TO CLOSE THE PUNCTURE, BUT THAT ALSO FAILED TO INSERT. THE GROIN PUNCTURE WAS ULTIMATELY MANAGED WITH MANUAL COMPRESSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137432 ↗
• InjuryDec 3, 2024Migration; Migration

  IT WAS REPORTED THAT PHYSICIAN DEPLOYED THE 6F CELT ON A 6F SHEATH. BLEEDING WAS NOTED UPON EJECTION. MANUAL COMPRESSION WAS APPLIED. ON FLUOROSCOPY IT WAS NOTED THAT THE IMPLANT WAS EMBOLIZED INTO THE TP TRUNK. DESPITE THE PATIENT HAVING ADEQUATE PULSES, VASCULAR SURGERY ELECTIVELY DECIDED TO RETRIEVE THE IMPLANT USING AN ENDOVASCULAR SNARE. THE PATIENT WAS ADMITTED TO THE ICU FOR HIGH BLOOD PRESSURE (NOT RELATED TO THE INCIDENT WITH THE CLOSURE DEVICE) AND WAS DISCHARGED WITH NO GROIN COMPLICATIONS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20829593 ↗
• InjuryMay 23, 2024Migration; Migration

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO USE A 6F CELT ACD TO CLOSE A 6F ARTERIAL PUNCTURE. UPON EJECTION, IT WAS NOTED THAT THERE WAS SIGNIFICANT BLEEDING AT THE PUNCTURE SITE SO MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. FLUOROSCOPY SHOWED THE DEVICE EMBOLIZED IN THE PROFUNDA. THE PATIENT HAD A SCHEDULED SURGERY AFTER THE PROCEDURE (PRE-SCHEDULED, NOT RELATED TO THE EMBOLIZED IMPLANT) WHICH PROCEEDED AS PLANNED. PATIENT SHOWED NO SIGNS OF LEG ISCHEMIA AND THE IMPLANT WAS LEFT IN THE PROFUNDA WITHOUT INCIDENT. PATIENT WAS DISCHARGED ACCORDING TO PLAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382089 ↗
• InjuryMay 23, 2024Migration; Migration

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO USE A 6F CELT ACD TO CLOSE A 6F ARTERIAL PUNCTURE. UPON EJECTION, IT WAS NOTED THAT THERE WAS SIGNIFICANT BLEEDING AT THE PUNCTURE SITE SO MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. FLUOROSCOPY SHOWED THE DEVICE EMBOLIZED IN THE SFA. THE PHYSICIAN DECIDED TO GET CONTRALATERAL ACCESS IN THE SAME SETTING AND WIRED PAST THE IMPLANT AND USED A SHORT STENT TO PIN THE STENT AGAINST THE WALL OF THE SFA. THERE WAS NO FURTHER INCIDENT AND NO NET BLEEDING COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382088 ↗
• MalfunctionApr 17, 2024Off-Label Use; Detachment of Device or Device Component; Off-Label Use; Detachment of Device or Device Component

  IT WAS REPORTED THAT PHYSICIAN ATTEMPTED TO CLOSE AN ARTERIAL PUNCTURE WITH A CELT ACD VASCULAR CLOSURE DEVICE OF UNKNOWN SIZE. WHEN THE PHYSICIAN ATTEMPTED TO EJECT THE IMPLANT, IT WAS NOTED THAT THE EJECTION FUNCTION DID NOT WORK PROPERLY, AND THE IMPLANT REMAINED CONNECTED TO THE DEVICE (AND THUS STILL IN THE PATIENT). THE PHYSICIAN DECIDED TO PULL THE IMPLANT OUT WHILE STILL CONNECTED TO THE DELIVERY SYSTEM AS ONE UNIT. HE THEN HELD MANUAL COMPRESSION TO ACHIEVE HAEMOSTASIS. THERE WERE NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19124160 ↗
• InjuryMar 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON ATTEMPTING TO USE THE CELT ACD DEVICE TO CLOSE A 6F ARTERIAL PUNCTURE, THE CUSTOMER THOUGHT THAT THE DISTAL WING WAS OPEN BUT WHEN ATTEMPTING TO WITHDRAW TO THE ARTERIOTOMY THE DEVICE SLIPPED OUT OF THE PATIENT. IT WAS NOTED THAT THE DISTAL WINGS DID NOT OPEN. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS AND THE PATIENT WAS DISCHARGED ON TIME WITHOUT INCIDENT. NO DEVICE WAS LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16617856 ↗
• InjuryFeb 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO CLOSE A 6F PUNCTURE SITE WITH A 6F CELT IMPLANT. IT IS NOT KNOWN WHETHER THE STEPS FOR DEPLOYMENT WERE CORRECTLY FOLLOWED. UPON RELEASE OF THE IMPLANT FROM THE DELIVERY SYSTEM, IMMEDIATE BLEEDING WAS NOTED AND MANUAL PRESSURE WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PHYSICIAN USED AN X-RAY FLUOROSCOPY AND DISCOVERED THAT THE IMPLANT WAS NOT AT THE ARTERIOTOMY SITE; IT WAS NOW BELOW THE KNEE JOINT. THE PHYSICIAN NOTED THAT THERE WERE NO CLINICAL SIGNS OF ISCHEMIA BUT HE STILL ELECTED TO RE-ACCESS THE GROIN ON THE OTHER SIDE AND PERFORMED AN ANGIOGRAM WHILE THE PATIENT WAS STILL DRAPED TO DETERMINE IF THERE WAS ANY EVIDENCE OF REDUCED BLOOD FLOW IN THE ARTERY BELOW THE IMPLANT. THIS ANGIOGRAM REVEALED THAT THE CELT IMPLANT WAS IN THE PROXIMAL PERONEAL ARTERY BUT THERE WAS NO EVIDENCE OF REDUCED FLOW. THE PATIENT WAS THEN BROUGHT TO RECOVERY WITH NO COMPLICATIONS. THE PATIENT REMAINED IN THE HOSPITAL FOR HYDRATION AND PLANNED REMOVAL OF THE DEVICE BY SNARING. THE IMPLANT WAS SUCCESSFULLY RETRIEVED AND REMOVED A FEW DAYS LATER. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS DISCHARGED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442135 ↗
• InjuryNov 23, 2022Migration; Migration

  IT WAS REPORTED THAT ON ATTEMPTING TO USE A 6F CELT TO CLOSE A 6F ARTERIAL ACCESS, THE CLIP MIGRATED ON EJECTION TO A POINT DISTAL TO THE ACCESS SITE IN THE ARTERY. MANUAL PRESSURE WAS APPLIED, AND HEMOSTASIS ACHIEVED. THE PATIENT HAD NO COMPLICATIONS AND WAS TRANSFERRED TO AN OBSERVATION UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15850719 ↗
• InjuryNov 23, 2022Migration; Migration

  IT WAS REPORTED THAT ON ATTEMPTING TO USE A 6F CELT TO CLOSE A 6F ARTERIAL ACCESS, THE FIRST AND SECOND SETS OF WINGS WERE DEPLOYED ACCORDING TO THE DEPLOYMENT INSTRUCTIONS AND EJECTED. HOWEVER, HEMOSTASIS WAS NOT ACHIEVED, AND AN X-RAY CONFIRMED THAT THE CLIP HAD MIGRATED DISTAL TO THE ACCESS POINT. MANUAL PRESSURE WAS APPLIED TO ACHIEVE HEMOSTASIS AND THE PATIENT HAD NO COMPLICATIONS AND NO FURTHER FOLLOW-UP WAS SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15850718 ↗
• InjurySep 23, 2022Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE USER FELT THAT THE PROXIMAL WING OF THE IMPLANT DID NOT SEEM TO DEPLOY AS THE HANDLE ON THE DELIVERY SYSTEM KEPT ROTATING IN A COUNTER-CLOCKWISE MANNER. IN VIEW OF THIS AND THE FACT THAT BLEEDING WAS NOTICED TO BE COMING UP AROUND THE SHEATH, THE USER DECIDED TO DISSECT DOWN TO THE DEVICE AND FOUND THAT THE IMPLANT WHILE STILL ATTACHED TO THE DELIVERY WAS IN THE SOFT TISSUE. 30 MINUTES OF MANUAL PRESSURE WAS USED TO ACHIEVE HEMOSTASIS AND THE DEVICE WITH THE IMPLANT ATTACHED WAS REMOVED FROM THE PATIENT. THE PATIENT HAD NO COMPLICATIONS AND WAS DISCHARGED ON TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15474607 ↗
• InjuryAug 5, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE USER ATTEMPTED TO CLOSE A 6F PUNCTURE SITE USING A CELT BUT REPORTED THAT THE IMPLANT "DISLODGED" AND THE IMPLANT TRAVELED INTO THE PROFUNDA FEMORIS ARTERY. MANUAL PRESSURE WAS APPLIED TO ACHIEVE HEMOSTASIS AND THE PATIENT WAS DISCHARGED ON TIME WITHOUT ANY FURTHER INCIDENT. THE IMPLANT REMAINS IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15173410 ↗
• InjuryDec 22, 2021Ejection Problem; Ejection Problem

  THE CELT DEVICE WAS SELECTED TO CLOSE A 6F ARTERIAL PUNCTURE. UPON EXECUTION OF THE FINAL STEP THE DELIVERY SYSTEM FAILED TO EJECT THE IMPLANT. THE DEPLOYER ELECTED TO PULL THE SYSTEM OUT (IMPLANT INCLUDED) AND REVERT TO MANUAL COMPRESSION. THERE WAS COMPLICATION TO THE PATIENT AND THEY WERE DISCHARGED SAME DAY ON TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13063823 ↗
• InjuryNov 16, 2021Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT THE OPERATOR USED A 6F CELT CLOSURE DEVICE TO CLOSE A 6F PUNCTURE IN THE FEMORAL ARTERY. UPON DEPLOYMENT OF BOTH SETS OF WINGS, THE IMPLANT FAILED TO EJECT AS THE LAST STEP. THE OPERATOR DECIDED TO PULL THE ENTIRE SYSTEM OUT OF THE ARTERIOTOMY. THE IMPLANT REMAINED ATTACHED TO THE DELIVERY SYSTEM. THE DEVICE WAS RETURNED TO VASORUM FOR EXAMINATION. THE PATIENT WAS STABLE AND DISCHARGED SAME DAY WITH NO COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820029 ↗
• InjuryJun 12, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ACCORDING TO THE DOCTOR, HE TURNED THE HANDLE CLOCKWISE, IT MADE THE 'CLICK', EVERYTHING SEEMED NORMAL BUT THE SET OF WINGS DIDN'T OPEN. WHEN PULLING BACK THE INSTRUMENT, THERE WAS NO RESISTANCE. DUE TO IMPLANT ERROR, ALSO DID NOT OPEN, THE SURGEON PULLED OUT THE CELT DEVICE BUT MANAGED TO LEAVE THE INTRODUCER SHEATH INSIDE AND CLOSED WITH AN ANGIO-SEAL DEVICE. THIS WAS A CARDIAC PROCEDURE.

  Patient problems: Blood Loss

  MAUDE report 8690653 ↗
• InjuryJun 12, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ACCORDING TO THE DOCTOR, HE TURNED THE HANDLE CLOCKWISE, IT MADE THE 'CLICK', EVERYTHING SEEMED NORMAL BUT THE SET OF WINGS DIDN'T OPEN. WHEN PULLING BACK THE INSTRUMENT, THERE WAS NO RESISTANCE AND THE TUBE SLIPPED OUT AND THE PATIENT SUFFERED A BIG BLOOD LOSS. AS THERE WAS NO RESISTANCE DUE TO NOT OPENING OF THE INNER 'STAR' BY PULLING EVERYTHING AGAINST THE ARTERIAL WALL, CELT DEVICE AND INTRODUCER SHEATH CAME OUT OF THE PATIENT AND THEN CLOSED BY MANUAL COMPRESSION. THE IMPLANT WAS DEPLOYED AFTER THE DEVICE WAS PULLED OUT OF PATIENT. IT WAS A CARDIAC PROCEDURE.

  Patient problems: Blood Loss

  MAUDE report 8690643 ↗
• InjuryDec 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE WAS DEPLOYED ON (B)(6) 2018. PATIENT HAD NO KNOWN SYMPTOMS POST DISCHARGE. ON (B)(6) 2018, THE PATIENT WAS BROUGHT IN FOR AN ANGIOGRAM AND THE IMPLANT WAS DISCOVERED IN THE RIGHT SFA. THE DOCTOR ATTEMPTED TO SNARE THE DEVICE VIA ANTEGRADE ACCESS. DURING THIS PROCESS THE DEVICE WAS LOST IN THE ORIGIN OF THE PROFUNDA ON THE CONTRALATERAL LEG. THE DOCTOR THEN PERFORMED CONTRALATERAL ACCESS ON THE RIGHT LEG, SNARED THE DEVICE AND DROPPED IT INTENTIONALLY IN A BRANCH OF THE INTERNAL ILIAC BECAUSE THIS IS A LOCATION WHERE BLOOD CAN EASILY PERFUSE AROUND THE IMPLANT AND CAUSE NO CLINICAL SEQUELLAE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8128570 ↗
• InjuryOct 25, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DEVICE WAS DEPLOYED ACCORDING TO THE PROPER STEPS, BUT WASN'T PULLED ALL THE WAY TO THE ARTERIOTOMY BEFORE TURNING STEP 2. IT WAS THEN RELEASED IN THE VESSEL. DOCTOR RE-ACCESSED IN THE SAME LOCATION AND PLACED A 6 X/ 40MM ZILVER STENT TO CAPTURE THE DEVICE AGAINST THE WALL OF THE SFA.

  Patient problems: Foreign Body In Patient

  MAUDE report 8004263 ↗
• InjuryOct 11, 2018Device Handling Problem; Device Handling Problem

  DEVICE WAS DEPLOYED. AFTER STEP 3, PHYSICIAN NOTED IMMEDIATE SIGNS OF A FAILED DEPLOYMENT (BLEEDING). MANUAL COMPRESSION WAS USED TO GAIN HEMOSTASIS. PHYSICIAN USED FLUOROSCOPY TO LOCATE THE IMPLANT WHICH APPEARED TO BE SOMEWHERE IN THE SFA. THE PHYSICIAN GAINED NEW 6F ANTEGRADE ACCESS. UPON FLUOROSCOPY IT WAS NOTED THAT THE DEVICE APPEARED TO BE IN THE TRIFURCATION, SPECIFICALLY IN THE ORIGIN OF THE ANTERIOR TIBIAL ARTERY WHICH WAS CHRONICALLY OCCLUDED BELOW THE IMPLANT (NOT DUE TO THE DEVICE). THE PHYSICIAN THEN ATTEMPTED TO SNARE THE DEVICE AND WAS SUBSEQUENTLY SUCCESSFUL IN DOING SO. AN ATTEMPT WAS MADE TO THEN REMOVE THE DEVICE AND SHEATH TOGETHER AFTER WEDGING THE IMPLANT INTO THE DISTAL END OF THE SHEATH. WHEN THE SHEATH WAS REMOVED, THE DEVICE APPEARED TO BE STUCK AT THE ARTERIOTOMY. AFTER SOME ATTEMPTS TO PULL IT OUT, THE PHYSICIAN FELT IT MADE SENSE CLINICALLY TO SEND THE PATIENT TO A LOCAL HOSPITAL FOR A SURGICAL CUTDOWN TO REMOVE THE SNARED DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7956250 ↗
• InjuryOct 10, 2017Device Handling Problem; Device Handling Problem

  DEVICE WAS DEPLOYED, NO INDICATION OF MALFUNCTION. AFTER STEP THREE (CLIP RELEASE) WAS PERFORMED, THERE WAS IMMEDIATE BLEEDING FROM THE PUNCTURE SITE. IMMEDIATE FLOURO AFTER REVEALED THE IMPLANT WAS IN THE MID SFA. MANUAL COMPRESSION ACHIEVED HEMOSTASIS. THE PHYSICIAN ELECTED TO RETRIEVE THE DEVICE USING AN EMBOLIC PROTECTION DEVICE (EMBOSHIELD NAV 6). THEY WERE ABLE TO CAPTURE THE DEVICE USING THIS METHOD. WHEN THE DEVICE WAS PULLED BACK TO THE END OF THE SHEATH, AN ATTEMPT WAS MADE TO PULL OUT THE SHEATH AND THE FILTER BASKET (CONTAINING THE IMPLANT) AS ONE UNIT. THE SHEATH CAME OUT, BUT THE FILTER BASKET COULD NOT BE PULLED OUT. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS AND THE PATIENT WAS TRANSFERRED TO A HOSPITAL FOR A SCHEDULED SURGICAL REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 6935337 ↗