Zenith TX2 Pro-Form G53424Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002534244), received between Feb 2, 2017 and Feb 2, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2017Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2013: THE PATIENT RECEIVED THE FOLLOWING DEVICES: ZTEG-2P-32-120-PF-US, LOT # E3017706, PLACED JUST ABOVE CELIAC ARTERY. ZTEG-2P-42-135-PF-US, LOT #E2974777, PLACED PROXIMAL TO ABOVE DEVICE. THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICES. A MOLDING BALLOON WAS USED WITHOUT DIFFICULTY OR COMPLICATIONS. NO PATIENT-RELATED ADVERSE EVENTS WERE OBSERVED DURING THE PROCEDURE. PER SITE, THE DEVICE WAS PATENT WITH NO KINK OR ENDOLEAK ON THE COMPLETION ANGIOGRAM. THE ANALYSIS NOTED A PATENT GRAFT WITH NO KINK. A PROXIMAL TYPE I AND A TYPE II ENDOLEAK WERE NOTED. (PLEASE NOTE: THIS OCCURRED PRIOR TO THE MANUFACTURER¿S REQUEST FOR REPORTING THIS EVENT). ON (B)(6) 2013 (DAY OF PROCEDURE): THE PATIENT DEVELOPED A LEFT LEG THROMBOSIS AND WAS TREATED WITH A LEFT FEMORAL-ILIO THROMBECTOMY. ON (B)(6) 2013 (THREE DAYS POST-PROCEDURE): THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2013 (53 DAYS POST-PROCEDURE): CT SCAN. ANALYSIS REVIEW: GRAFT PATENT, INTACT WITH NO KINK. A DISTAL TYPE I ENDOLEAK AND A TYPE II ENDOLEAK WERE NOTED. MAXIMUM ANEURYSM DIAMETER = 59.0 MM. ON (B)(6) 2013 (214 DAYS POST-PROCEDURE): CT SCAN. ANALYSIS REVIEW: GRAFT

  Patient problems: Aneurysm

  MAUDE report 6295898 ↗