Cook CelectRecalls & reported problems across all models
William Cook Europe ApS · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 874
- Deaths reported
- 11
- Injuries reported
- 529
- Recalls
- 1
We found 10 models of Cook Celect by William Cook Europe ApS in the FDA's device registry (GUDID). Together they are named in 874 adverse event reports in the FDA's MAUDE database, received between Oct 14, 2011 and Dec 10, 2025 — classified as 11 deaths, 529 injuries, 329 malfunctions.
The most frequently reported specific device problem is “Structural Problem” (282 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Cook Celect recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 14, 2022Terminated
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Z-0876-2022 · Root cause: Labeling design · names 3 of these models · Recall details · FDA record ↗
Most reported Cook Celect problems
Device problems
- Structural Problem282
- Appropriate Device Problem Term/Code Not Available256
- Device Tipped Over182
- Difficult to Remove138
- Malposition of Device120
- Obstruction of Flow71
- Unintended Movement65
- Insufficient Device Problem Information60
Patient problems
- Perforation of Vessels350
- Internal Organ Perforation215
- Insufficient Information139
- No Known Impact Or Consequence To Patient138
- No Consequences Or Impact To Patient111
- Pain111
- Anxiety108
- No Clinical Signs, Symptoms or Conditions93
Cook Celect models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cook Celect G34309FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall1 death230 reports
- Cook Celect G34502FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall2 deaths165 reports
- Cook Celect G34505FILTER, INTRAVASCULAR, CARDIOVASCULAR1 recall1 death131 reports
- Cook Celect G52914FILTER, INTRAVASCULAR, CARDIOVASCULAR2 deaths99 reports
- Cook Celect G48373FILTER, INTRAVASCULAR, CARDIOVASCULAR1 death78 reports
- Cook Celect G52915FILTER, INTRAVASCULAR, CARDIOVASCULAR1 death64 reports
- Cook Celect G52909FILTER, INTRAVASCULAR, CARDIOVASCULAR3 deaths47 reports
- Cook Celect G48372FILTER, INTRAVASCULAR, CARDIOVASCULAR31 reports
- Cook Celect G48378FILTER, INTRAVASCULAR, CARDIOVASCULAR27 reports
- Cook Celect G03767FILTER, INTRAVASCULAR, CARDIOVASCULAR2 reports
Recent Cook Celect adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2025Activation Problem; Activation Problem
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN UNKNOWN PROCEDURE IN WHICH THE COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET, G34309, WAS USED. DEVICE WAS PREPPED PER PROTOCOL. FILTER WOULD NOT RELEASE FROM HOOK UPON PRESSING BLUE BUTTON. RE-SHEATHED FILTER AND REMOVED FROM THE SHEATH. DEPLOYED FILTER ON TABLETOP. OPENED NEW FILTER AND WAS ABLE TO DEPLOY THAT FINE. PATIENT OUTCOME: NO ADDITIONAL PROCEDURES NECESSARY. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23765994 ↗InjurySep 19, 2025Device Tipped Over; Device Tipped Over
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: INFERIOR VENA CAVA (IVC) FILTER DEPLOYMENT WAS UNSUCCESSFUL. TWO RETRIEVAL SETS WERE UTILIZED TO REMOVE THE FILTER. A NEW ACCESS SITE WAS ESTABLISHED, AND A SECOND DEVICE OF THE SAME TYPE WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: DELAY WITH UNKNOWN OF THE LENGHT OF TIME. WHAT WAS THE INDICATION FOR FILTER PLACEMENT? PE PREVENTION. IF KNOWN, HOW LONG WAS THE FILER IMPLANTED IN THE PATIENT? FEW MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23096241 ↗InjurySep 11, 2025Device Tipped Over; Device Tipped Over
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE CELECT FILTER APPEARED FINE BEFORE INSERTION, BUT AFTER BEING INTRODUCED TO THE PATIENT, IT APPEARED SIGNIFICANTLY TILTED ON THE IMAGING SCREEN. AS A RESULT, THE DOCTOR HAD TO REMOVE IT AND REPLACE IT WITH A NEW FILTER TO ENSURE PATIENT SAFETY. PATIENT OUTCOME: NO HARM TO PATIENT REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23023487 ↗InjurySep 5, 2025Device Tipped Over; Activation Problem; Device Tipped Over; Activation Problem
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: INFERIOR VENA CAVA (IVC) FILTER DEPLOYMENT WAS UNSUCCESSFUL. TWO RETRIEVAL SETS WERE UTILIZED TO REMOVE THE FILTER. A NEW ACCESS SITE WAS ESTABLISHED, AND A SECOND DEVICE OF THE SAME TYPE WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. PATIENT OUTCOME: DELAY WITH UNKNOWN OF THE LENGTH OF TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22976479 ↗InjuryApr 29, 2025Device Tipped Over; Device Tipped Over
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A 86-YEAR-OLD FEMALE UNDERWENT A FILTER PLACEMENT PROCEDURE IN WHICH A G34309-IGTCFS-65-1-JUG-CELECT-PT, WAS USED. THE FILTER DID NOT DEPLOY CORRECTLY. IT WAS TILTED INTO THE WALL. A GÜNTHER TULIP VENA CAVA FILTER RETRIEVAL SET HAD TO BE USED TO RETRIEVE THE FILTER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER G34309-IGTCFS-65-1-JUG-CELECT-PT. ADDITIONAL INFORMATION RECEIVED 10JAN2025: THE FILTER WAS DEPLOYED VIA JUGULAR APPROACH. DURING IMPLANTATION PROCEDURE DIFFICULTIES WERE XTREME TILT BUT NO PERFORATION WERE ENCOUNTERED. THE FILTER WAS RETRIEVED WITH FILTER RETRIEVAL SETS AND SHEATHS. THEY HAD TO USE MULTIPLE TYPES OF RETRIEVAL SETS. THE TILT WAS OBSERVED RIGHT AFTER DEPLOYMENT THE TILT DID EVOLVE DURING FOLLOW UP IMAGES FROM THE INITIAL IMPLANT ORIENTATION. PATIENT OUTCOME: DELAY, THE RETRIEVAL AND HAD TO DO ANOTHER PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21924293 ↗InjuryFeb 12, 2025Premature Activation; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21362586 ↗MalfunctionFeb 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A 52-YEAR-OLD FEMALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE COOK CELECT PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET, G34309, WAS USED. THE FILTER PUNCTURED THROUGH TO DISTAL END OF THE SHEATH BEFORE THEY WERE READY TO DEPLOY. THE CASE WAS ABLE TO BE COMPLETED ONCE THE FAULTY DEVICE WAS REMOVED AND A NEW DEVICE WAS OPENED. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21311776 ↗InjuryJan 13, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: FILTER DEPLOYMENT ON JUG, THE DEPLOYMENT RELEASE MECHANISM WAS GETTING CAUGHT ON THE FILTER HOOK WHILE THE PHYSICIAN WAS TRYING TO RELEASE THE FILTER. THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING THE DEVICE. DUE TO THE EVENT, IT CAUSED THE FILTER TO TILT, THEREFORE THE PHYSICIAN HAD TO USE A COOK, GTRS-200-RB RETRIEVAL SET TO READJUST THE FILTER. THERE WERE NO ISSUES WHEN RELEASING FROM THE FEM SYSTEM AND LOADING ONTO THE JUG SYSTEM. RE-SHEATHING OVER THE FILTER WITH THE JUG SYSTEM WENT SMOOTHLY. PATIENT OUTCOME: THE PHYSICIAN HAD TO GO IN WITH A RETRIEVAL SET AND READJUST THE FILTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21136309 ↗InjuryJan 10, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ACCORDING TO THE INITIAL REPORTER: FILTER DEPLOYMENT ON JUG, THE DEPLOYMENT RELEASE MECHANISM WAS GETTING CAUGHT ON THE FILTER HOOK WHILE THE PHYSICIAN WAS TRYING TO RELEASE THE FILTER. THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING THE DEVICE. THE EVENT IT CAUSED THE FILTER TO TILT, THEREFORE THE PHYSICIAN HAD TO USE A COOK, GTRS-200-RB RETRIEVAL SET TO READJUST THE FILTER. ADDITIONAL INFORMATION RECEIVED 23DEC2024: THERE WERE NO ISSUES WHEN RELEASING FROM THE FEM SYSTEM AND LOADING ONTO THE JUG SYSTEM. RE-SHEATHING OVER THE FILTER WITH THE JUG SYSTEM WENT SMOOTHLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21126761 ↗MalfunctionNov 12, 2024Difficult or Delayed Activation; Activation Failure; Difficult or Delayed Activation; Activation Failure
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING THE DEPLOYMENT THE PHYSICIAN NOTICED ONE FOOT OF THE FILTER WOULD NOT EXPAND. DECISION WAS MADE TO REMOVE THE DEFECTIVE DEVICE. A SECOND FILTER WAS OPENED AND DEPLOYED WITHOUT ISSUE. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20664461 ↗InjuryNov 11, 2024Premature Activation; Improper or Incorrect Procedure or Method; Premature Activation; Improper or Incorrect Procedure or Method
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20651024 ↗InjuryNov 6, 2024Activation Failure; Activation Failure
ACCORDING TO THE INITIAL REPORTER, DURING THE DEPLOYMENT, THE PHYSICIAN NOTICED ONE FOOT OF THE FILTER WOULD NOT EXPAND. DECISION WAS MADE TO REMOVE THE DEFECTIVE DEVICE. A SECOND FILTER WAS OPENED AND DEPLOYED WITHOUT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620943 ↗InjuryNov 5, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ACCORDING TO THE INITIAL REPORTER, THE FILTER WAS PLACED INCORRECTLY. THE LEAD TECH SAID THAT THE DOCTOR SAID IT MISFIRED. THE TECH SAID IT WAS MISPLACED. THEY TRIED TO RETRIEVE IT BUT WERE UNSUCCESSFUL. THE TOP IS IN THE COMMON AND THE PRONGS ARE IN THE RIGHT INTERNAL. THEY WILL ATTEMPT AGAIN TO RETRIEVE IT WITHIN THE NEXT FEW WEEKS. ADDITIONAL INFORMATION RECEIVED: - WAS THE FILTER ADVANCED BY FEMORAL OR JUGULAR INTRODUCER? FEMORAL - WERE THE DIFFICULTIES AT DEPLOYMENT DUE TO THE HANDLE (BLUE RELEASE BUTTON)? NOT THE HANDLE. THE FILTER WAS NOT FULLY INTRODUCED. - WAS THE RETRIEVAL PROCEDURE BY USING GTRS? THE SNARE WAS IN THE RETRIEVAL KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20616003 ↗InjuryOct 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT IS ALLEGED THAT THE PATIENT RECEIVED A CELECT PLATINUM INFERIOR VENA CAVA (IVC) FILTER ON (B)(6) 2019. IT IS ALLEGED THAT THE PATIENT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20532483 ↗MalfunctionOct 25, 2024Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: UPON INSERTING THE FILTER INTO THE SHEATH, THE PHYSICIAN DID NOT INITIALLY FEEL RESISTANCE, BUT THEN FELT A GREAT DEAL OF RESISTANCE AND THEN NO AGAIN NO RESISTANCE. THE PHYSICIAN KNEW THAT SOMETHING MUST HAVE OCCURRED SO THE ENTIRE SYSTEM WAS REMOVED AS A WHOLE. THE TINES OF THE FILTER BECAME CAUGHT AT THE ACCESS SITE. PHYSICIAN PERFORMED A SMALL CUT DOWN TO REMOVE THE DEVICE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20531725 ↗
Other William Cook Europe ApS products
All William Cook Europe ApS devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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