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COOK G47442Recalls & 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
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002474427), received between Nov 17, 2021 and Nov 22, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (2 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.

Most reported problems

Device problems

  • Physical Resistance/Sticking2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 22, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

    DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: POST DEPLOYMENT OF ZDEG, GREEN SLEEVE AND TRIGGER WIRES WOULD NOT RELEASE. EXCESSIVE FORCE REQUIRED TO RELEASE TRIGGER WIRES CAUSING DILATOR AND DEVICE TO MIGRATE DISTALLY RESULTING IN ENCROACHMENT OF THE CELIAC ARTERY. SUBSEQUENT STENT IMPLANTATION WAS REQUIRED TO PRESERVE CELIAC ARTERY. PATIENT OUTCOME: NO UNINTENDED DEVICE REMAINED INSIDE THE PATIENT´S BODY. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO OCCURRENCE. A CELIAC COVERED STENT WAS PLACED TO PROTECT CELIAC FROM STENT MIGRATION AND MAL-PERFUSION. 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 12852561 ↗
  • InjuryNov 17, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

    DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: POST DEPLOYMENT OF ZDEG, GREEN SLEEVE AND TRIGGER WIRES WOULD NOT RELEASE. EXCESSIVE FORCE REQUIRED TO RELEASE TRIGGER WIRES CAUSING DILATOR AND DEVICE TO MIGRATE DISTALLY RESULTING IN ENCROACHMENT OF THE CELIAC ARTERY. SUBSEQUENT STENT IMPLANTATION WAS REQUIRED TO PRESERVE CELIAC ARTERY. PATIENT OUTCOME: NO UNINTENDED DEVICE REMAINED INSIDE THE PATIENT´S BODY. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO OCCURRENCE. A CELIAC COVERED STENT WAS PLACED TO PROTECT CELIAC FROM STENT MIGRATION AND MAL-PERFUSION. 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 12826158 ↗

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Sources and updates

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