COOK G47455Recalls & reported problems
William Cook Europe ApS · Zenith TX2, Dissection Endovascular Graft with Pro-form, and the Z-Trak Plus Introduction System-Straight Component · Class 3 · Implant
All models of COOK (26)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002474557), received between Dec 19, 2022 and Aug 7, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking3
- Activation Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionFeb 8, 2023Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking
DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE TRIGGER WIRES WERE ALL TWISTED UP AROUND THE DEVICE. IT TOOK 15 TO 20 MINUTES TO REMOVE THE TRIGGER WIRES. THEY EVENTUALLY REALIZED THE WIRES WERE TWISTED AROUND THE DEVICE. ONE PHYSICIAN LATER SAID THAT HE SAW THE OTHER PHYSICIAN TWISTING THE TRIGGER WIRES INSTEAD OF PULLING THEM OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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 16320660 ↗MalfunctionDec 19, 2022Physical 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 16002969 ↗
Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices
- Endurant® IIs ESBF2814C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls34 deaths254 reports
- Endurant® IIs ESBF3214C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls19 deaths173 reports
- Endurant® IIs ESBF3614C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall37 deaths214 reports
- Endurant® IIs ESBF2514C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls18 deaths136 reports
- Endurant® IIs ESBF2314C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls9 deaths60 reports
- RelayPro Thoracic Stent-Graft System 28-N4-34-154-34UBolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment3 recalls7 reports
- Vela Proximal Endograft System A34-34/C100-O20 VEndologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths152 reports
- Endurant® II ETCF2828C49EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls7 deaths44 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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