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Zenith TX2 Pro-Form G53450Recalls & reported problems

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

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002534503), received between Jan 31, 2017 and Oct 22, 2021 — classified as 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Device Dislodged or Dislocated2
  • Appropriate Device Problem Term/Code Not Available1
  • Off-Label Use1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
  • Vascular Dissection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: COMPONENT SEPARATION. ON (B)(6) 2016: INDEX PROCEDURE: COOK 4-VESSEL CUSTOM BRANCHED ENDOGRAFT WITH TAA PROXIMAL EXTENSION (ZTEG, ESBE AND TBE) ON (B)(6) 2020: COMPONENT SEPARATION BETWEEN THE CUSTOM ENDOGRAFT AND TAA EXTENSION -> REPAIRED WITH ALPHA ((B)(4)) ON (B)(6) 2021: PATIENT WAS TRANSFERRED FROM AN OUTSIDE HOSPITAL WITH SYMPTOMATIC TAAA/SEPARATION OF ALPHA GRAFT FROM CUSTOM ENDOGRAFT -> DUE TO OTHER COMORBIDITIES, NO INTERVENTION WAS PERFORMED ((B)(4)).

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 12680727 ↗
  • InjuryOct 18, 2021Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 12645648 ↗
  • InjuryJan 31, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE ZENITH TX2 TAA ENDOVASCULAR GRAFT WAS PLACED PER IFU WITH GREAT OUTCOME RESOLVING THE PATIENT¿S PAIN. ABOUT 30 HOURS POST OP THE PATIENT HAD DISSECTED RETROGRADE INTO THE ASCENDING AORTA. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR OPEN AORTIC REPAIR. PATIENT OUTCOME. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR OPEN AORTIC REPAIR. IT IS UNKNOWN AT THIS TIME THE PATIENTS CONDITION.

    Patient problems: Vascular Dissection

    MAUDE report 6288748 ↗

Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices

All SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices →

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