COOKRecalls & reported problems across all models
William Cook Europe ApS · 26 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 97
- Deaths reported
- 7
- Injuries reported
- 57
- Recalls
- 0
We found 26 models of COOK by William Cook Europe ApS in the FDA's device registry (GUDID). Together they are named in 97 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2016 and May 12, 2026 — classified as 7 deaths, 57 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (30 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. 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
Most reported COOK problems
Device problems
- Physical Resistance/Sticking30
- Component Incompatible11
- Off-Label Use10
- Material Frayed8
- Improper or Incorrect Procedure or Method7
- Malposition of Device7
- Material Fragmentation7
- Flaked5
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- No Known Impact Or Consequence To Patient20
- No Consequences Or Impact To Patient6
- Insufficient Information5
- No Information5
- Vascular Dissection5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Death4
COOK models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- COOK G48303Tube, tracheal (w/wo connector)29 reports
- COOK G23646Tube, tracheal (w/wo connector)9 reports
- COOK G47493SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 deaths9 reports
- COOK G47448SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 reports
- COOK G47452SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 reports
- COOK G47455SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 reports
- COOK G47467SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT4 reports
- COOK G47440SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- COOK G47496SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT3 reports
- COOK G23645Tube, tracheal (w/wo connector)2 reports
- COOK G53517Tube, tracheal (w/wo connector)2 reports
- COOK G47442SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- COOK G47444SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- COOK G47449SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- COOK G47451SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- COOK G47456SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- COOK G47457SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- COOK G47476SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death2 reports
- COOK G47480SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 deaths2 reports
- COOK G47485SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 reports
- COOK G47468SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- COOK G47474SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 death1 report
- COOK G47475SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- COOK G47478SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- COOK G47487SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
- COOK G47491SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 report
Recent COOK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 12, 2026Material Fragmentation
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: COATING COMES OFF WHEN INSERTING FEED INTO THE TUBE OR CANNULA 1 PIECE KEPT, BUT ALSO THE CASE WITH OTHERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25146410 ↗InjuryDec 22, 2025Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Apnea
MAUDE report 23862319 ↗InjuryDec 22, 2025Deformation Due to Compressive Stress; Material Deformation; Deformation Due to Compressive Stress; Material Deformation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Apnea
MAUDE report 23862266 ↗MalfunctionAug 7, 2025Activation Problem; Activation 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 22735554 ↗MalfunctionMay 1, 2024
WHILE UNSHEATHING GRAFT TO BEGIN FENESTRATIONS, SURGEON HAD DIFFICULTY GETTING GRAFT TO COME OUT. WHEN GRAFT FINALLY UNSHEATHED, SURGEON NOTICED THAT PART OF DEPLOYMENT SYSTEM WAS BROKEN RENDERING SYSTEM UNUSABLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19220094 ↗MalfunctionFeb 21, 2024Off-Label Use; Physical Resistance/Sticking; Off-Label Use; Physical Resistance/Sticking
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 18745633 ↗MalfunctionJan 25, 2024Off-Label Use; Use of Device Problem; Difficult to Advance; Off-Label Use; Use of Device Problem; Difficult to Advance
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ZDES-36-80-US LOT E4358915 DID NOT HAVE A SMOOTH TIP TO SHEATH TRANSITION AND THEREFORE COULD NOT BE ADVANCED INTO A SHEATH. DEVICE WAS NOT DEPLOYED. PATIENT OUTCOME: THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18578103 ↗MalfunctionJan 8, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DIFFICULT TO RELEASE THE SAFETY WIRES. NO TORTUOSITY. THE JUNCTION WAS NOT TIGHT. THE GRAFT WAS LANDED AT THE LEVEL AT THE LOCATION OF THE SUBCLAVIAN. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18462340 ↗MalfunctionDec 22, 2023Off-Label Use; Physical Resistance/Sticking; Off-Label Use; Physical Resistance/Sticking
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A REPAIR OF A CHRONIC DISSECTION WITH EXISTING PROXIMAL STENT GRAFT IN WHICH THE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT, G47448, WAS USED. THE GRAFT WAS BEING DEPLOYED INSIDE AN EXISTING SURGICAL GRAFT FROM ANOTHER MANUFACTURER. THERE WAS NO NOTABLE TORTUOSITY OR ANGULATION. THE DEVICE DEPLOYED FINE AND AS INTENDED, HOWEVER THE SAFETY WIRE RELEASE WAS EXTREMELY DIFFICULT TO RELEASE. ANOTHER UNIT OF THE SAME, G47448- LOT E4468992, WAS PLACED DISTALLY WITH NO ISSUES ON RELEASE OR DEPLOYMENT. 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 18388843 ↗MalfunctionDec 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DEVICE WAS PLACED AND EVERYTHING APPEARED FINE. SOMEHOW, THE DEVICE GOT STUCK IN A COOK SHEATH OR A DRY-SEAL. IN ANY EVENT, THE STENT WAS PULLED OUT / THROUGH THE DRY-SEAL. AT THIS POINT, THE PHYSICIAN ELECTED TO OPEN UP A NEW ZDES-36-180 TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON 21AUG2023: PATIENT CAME IN EMERGENTLY AND WAS IN OPEN ASCENDING ARCH REPAIR FOR AORTIC DISSECTION FOR >6 HOURS PRIOR TO THE STENT GOING IN. STENT PLACEMENT WENT VERY QUICKLY. UNSURE IF STENT WAS CAUGHT IN ZDES SHEATH OR DRYSEAL SHEATH. TRIGGER WIRES REMOVED WITH EASE. DESPITE REQUEST, PHYSICIAN REMOVED POSITIONER AND COOK ZDES SHEATH WITHOUT WATCHING ON ANGIO AND DID SO VERY QUICKLY. EVERYTHING LOOKED GOOD UP UNTIL SHEATH/ POSITIONER REMOVAL. I REQUESTED THE PHYSICIAN TO WATCH THE DEVICE POSITIONER COME THROUGH THE STENT UNDER FLORO AND PHYSICIAN DID NOT USE FLORO AND PULLED COOK ZDES SHEATH AND POSITIONER OUT QUICKLY. I LOOKED FROM THE SCREEN TO THE TABLE IMMEDIATELY AFTER REQUESTING FLORO AND SAW THE STENT ON THE TABLE. THERE WAS VERY MINIMAL IMAGING AND HAPPENED VERY FAST. ZDES STENT CAME OUT WITH THE COOK
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18323937 ↗InjuryOct 10, 2023Off-Label Use; Physical Resistance/Sticking; Off-Label Use; Physical Resistance/Sticking
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 17903031 ↗MalfunctionSep 26, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
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 17815591 ↗InjuryAug 29, 2023Component Incompatible; Improper or Incorrect Procedure or Method; Component Incompatible; Improper or Incorrect Procedure or Method
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: BLUE PLASTIC CAME OFF THE FROVA BOUGIE WHILE INTUBATING. PATIENT OUTCOME: NO ADDITIONAL PROCEDURE WAS REQUIRED DUE TO THIS OCCURRENCE. NO ADVERSE EFFECT ON THE PATIENT WAS REPORTED DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17639183 ↗InjuryJul 27, 2023Component Incompatible; Improper or Incorrect Procedure or Method; Component Incompatible; 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: Foreign Body In Patient
MAUDE report 17404813 ↗MalfunctionJun 21, 2023Off-Label Use; Physical Resistance/Sticking; Off-Label Use; Physical Resistance/Sticking
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ZDEG TRIGGER WIRE RELEASE MECHANISM WOULD NOT RELEASE FROM DEVICE. TRIGGER WIRES COULD NOT INITIALLY BE REMOVED AFTER FULLY UNSHEATHING ZDEG INSIDE THE THORACIC AORTA. UNABLE TO CONFIRM NOR DENY THAT THE TRIGGER WIRE RELEASE MECHANISM HAD NOT BEEN ROTATED PRIOR TO ATTEMPTING TO REMOVE FROM TRIGGER WIRES. PHYSICIAN WAS ABLE TO PRY MECHANISM APART ENOUGH TO RELEASE WIRES AND SUCCESSFULLY DEPLOY THE DEVICE. ADDITIONAL INFORMATION RECEIVED (B)(6)2023 : THE PHYSICIANS DID USE (B)(4) SETS OF FORCEPS TO CORRECT THE STUCK RELEASE MECHANISM, BUT NOT TO PHYSICALLY REMOVE THE TRIGGER WIRES. THE TEAM ACTUALLY USED THE FORCEPS TO TRY AND SPREAD THE GREEN TRIGGER MECHANISM APART IN AN EFFORT TO ACCESS THE WIRES. THEY BROKE BOTH FORCEPS IN THE PROCESS. ALTHOUGH THE SCRUB TEAM SAID THE DOCTOR ALSO ¿BEAT THE DEVICE A LOT¿ MEANING THE GREEN MECHANISM. THE PHYSICAL MANIPULATION OF THE MECHANISM WAS ENOUGH TO RELEASE ENOUGH TENSION AND THE TEAM WAS ABLE TO REMOVE THE MECHANISM WITH ALL WIRES INTACT. THE ONLY WIRE THAT LOOKED DAMAGED WAS THE STAINLESS STEEL WIRE, WHICH WAS BENT IN A 90 DEGREE ANGLE. PATIENT OUTCOME: THE GRAFT WAS FULLY DEPLOYED AND LA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17168969 ↗
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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