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COOK G47444Recalls & 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

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 10827002474441), received between Mar 19, 2021 and Apr 7, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Physical Resistance/Sticking2

Patient problems

  • Rupture2

Recent adverse event reports

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

  • InjuryApr 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

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

    Patient problems: Rupture

    MAUDE report 11626841 ↗
  • InjuryMar 19, 2021Physical 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: Rupture

    MAUDE report 11523494 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.