Zenith TX2 Pro-Form G53432Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002534329), received between Mar 30, 2015 and Mar 21, 2022 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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

Recent adverse event reports

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

• DeathMar 21, 2022Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: (B)(6)-YEAR-OLD FEMALE WITH AN EXTENSIVE ANEURYSMAL DISEASE ALONG WITH A CHRONICALLY OCCLUDED CELIAC ARTERY AND A VERY TORTUOUS AORTA WITH A HISTORY OF FIRST STAGE ELEPHANT TRUNK REPAIR UNDERWENT A SUCCESSFUL STAGED ENDOVASCULAR TAAA REPAIR: THORACIC STENT AND ILIOFEMORAL BYPASS PLACED ON (B)(6) 2013 FOLLOWED BY CUSTOM 3-VESSEL BRANCHED STENT GRAFT AND THORACIC EXTENSION ON (B)(6) 2013. ON (B)(6) 2014, SUBJECT WAS SEEN WITH A LARGE TYPE III ENDOLEAK BETWEEN THE THORACIC EXTENSION AND THE MAIN BODY STENT GRAFTS. THIS WAS SUCCESSFULLY TREATED ON (B)(6) 2014 BY PLACING A TX2 ZTEG 36-202 AS A BRIDGE STENT GRAFT. THE SUBJECT TOLERATED THE PROCEDURE WELL. ON (B)(6) 2014 THE ZTEG-2P-34-152-PF-US AND (B)(4) THORACO ABDOMINAL GRAFT HAD SEPARATED. BY REPORT, THE SEPARATION WAS BRIDGED WITH A ZTEG-36-202 FIVE DAYS LATER. IMPLANTATION IMAGING OR SHORT TERM FOLLOW UP WAS NOT PROVIDED. THE PATIENT REPORTEDLY PRESENTED THREE MONTHS LATER ((B)(6) 2014) WITH ABDOMINAL PAIN AND WAS FOUND TO HAVE A TYPE IIIA ENDOLEAK FROM ZTEG-36-202 AND (B)(4) THORACO ABDOMINAL GRAFT SEPARATION. THE SEPARATIONS WERE THE RESULT OF DISTAL THORACIC SUPRARENAL ABDOMINA

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

  MAUDE report 13838826 ↗
• MalfunctionOct 9, 2019Malposition of Device; Appropriate Device Problem Term/Code Not Available; Malposition of Device; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: No Code Available

  MAUDE report 9171307 ↗
• InjuryMar 30, 2015Leak/Splash

  DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: PRE-PROCEDURE CT SHOWED A PROXIMAL DESCENDING THORACIC ANEURYSM, MAXIMUM DIAMETER 5.67 CM, LENGTH 15.0 CM. ON (B)(6) 2014, THE PATIENT RECEIVED A ZTEG-2P-36-202-PF-US. THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICE. NO PATIENT-RELATED ADVERSE EVENTS WERE OBSERVED DURING THE PROCEDURE. PER SITE AND CORE LAB, THE DEVICE WAS PATENT WITH NO KINK OR ENDOLEAK ON THE COMPLETION ANGIOGRAM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 (TWO DAYS POST-PROCEDURE). ON (B)(6) 2014 (43 DAYS POST-PROCEDURE) ONE MONTH FOLLOW-UP CT SCAN: CORE LAB REVIEW: PATENT, INTACT GRAFT WITH NO EVIDENCE OF KINK, TYPE II ENDOLEAK WAS NOTED. THE MAXIMUM ANEURYSM DIAMETER MEASURED 58 MM AND THE ANEURYSM LENGTH MEASURED 146.9 MM. ON (B)(6) 2015 (263 DAYS POST-PROCEDURE) SIX MONTH FOLLOW-UP CT SCAN: CORE LAB REVIEW: PATENT, INTACT GRAFT WITH NO EVIDENCE OF KINK OR MIGRATION. A TYPE II ENDOLEAK AND A TYPE IV ENDOLEAK WERE NOTED. THE MAXIMUM ANEURYSM DIAMETER MEASURED 55.1 MM AND THE ANEURYSM LENGTH MEASURED 150.6 MM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 4643226 ↗