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COOK G47449Recalls & 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002474496), received between Jan 21, 2022 and Apr 4, 2023 — classified as 2 malfunctions.

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.

  • MalfunctionApr 4, 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 16672189 ↗
  • MalfunctionJan 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

    DESCRIPTION OF EVENT: ACCORDING TO THE INITIAL REPORTER: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A TVAR PROCEDURE IN WHICH THE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT, G47449, WAS USED. THE TRIGGER WIRE KNOB WAS UNABLE TO BE RELEASED. THE PHYSICIAN HAD TO USE EXCESSIVE FORCE AND PULLED 4-5 TIMES WITH SUCH FORCE WITH SMALL BREAKS IN BETWEEN FROM PULLING SO HARD. THE PHYSICIAN STATED THAT IN USING ONLY THESE PRODUCTS IN FIFTEEN YEARS THIS IS THE HARDEST HE HAS EVER HAD TO PULL OF ANY DEVICE. IT WAS NOTED THERE WAS HARDLY ANY TORTUOUS ANATOMY, NO CALCIFICATION, AND ACCESS WAS GOOD. THE PHYSICIAN WAS EVENTUALLY ABLE TO RELEASE THE GRAFT COMPONENT. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13313195 ↗

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Sources and updates

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