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Zenith TX2 Pro-Form G53452Recalls & reported problems

William Cook Europe ApS · Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component · Class 3 · Implant

All models of Zenith TX2 Pro-Form (15)

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 10827002534527), received between Oct 18, 2021 and Oct 20, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Device Dislodged or Dislocated2
  • Off-Label Use1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2

Recent adverse event reports

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

  • InjuryOct 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: COMPONENT SEPARATION. SECONDARY PROCEDURE DONE, ALPHA 38 X 167 IMPLANTED. ON (B)(6) 2017: THORACIC ENDOGRAFT (ALPHA 38X167). RIGHT GROIN CUTDOWN. ULTRASOUND-GUIDED ACCESS OF LEFT COMMON FEMORAL ARTERY. ((B)(4)). ON (B)(6) 2018: TEVAR RE-LINING DISTAL DTA BETWEEN PREVIOUS TEVAR AND FENESTRATED ENDOGRAFTS WITH 40X150MM GORE CTAG. ((B)(4)). 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 12666567 ↗
  • InjuryOct 18, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

    DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: COMPONENT SEPARATION BETWEEN ZTEG 2PT (42 TO 38) AND MAIN BODY (36 PROX). IMPLANT PROCEDURE DATE (B)(6) 2015. COMPONENT SEPARATION (B)(6) 2016. (B)(6) 2017: THORACIC ENDOGRAFT (ALPHA 38X167). RIGHT GROIN CUTDOWN. ULTRASOUND-GUIDED ACCESS OF LEFT COMMON FEMORAL ARTERY. (B)(4) (B)(6) 2018: TEVAR RE-LINING DISTAL DTA BETWEEN PREVIOUS TEVAR AND FENESTRATED ENDOGRAFTS WITH 40X150MM GORE CTAG. (B)(4) 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 12645617 ↗

Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices

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Sources and updates

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