Zenith TX2 Pro-Form G53459Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002534596), received between Mar 17, 2017 and Mar 17, 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 18, 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.

• InjuryMar 17, 2017Leak/Splash; Leak/Splash

  DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2012, THE PATIENT RECEIVED ONE TBE-38-77-PF-US (LOT # E2675237). THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICE. A MOLDING BALLOON WAS USED WITHOUT DIFFICULTY. 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 CONCURRED WITH THE SITE¿S ASSESSMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 (SIX DAYS POST-PROCEDURE). PER ANALYSIS, ALL FOLLOW-UP IMAGING INDICATED NO ISSUES, ALTHOUGH THE ANNUAL CT SCANS AT 2 YEARS AND 3 YEARS POST-IMPLANT WERE NON-CONTRAST, AND THE 4-YEAR FOLLOW-UP CT SCAN WAS NOT DONE. THE ANEURYSM DIAMETER DECREASED FROM 5.76 CM AT ONE MONTH POST-IMPLANT TO 5.3 CM AT 5 YEARS. ON (B)(6) 2017: CT SCAN (1860 DAYS POST-PROCEDURE): PER INVESTIGATIVE SITE: GRAFT PATENT, INTACT WITH NO MIGRATION. AN ENDOLEAK OF UNKNOWN TYPE WAS NOTED. MAXIMUM ANEURYSM DIAMETER = 4.5 CM. PATIENT OUTCOME: NO ADVERSE EVENTS RELATED TO THE STUDY PROCEDURE OR THE DEVICE, AND NO SECONDARY INTERVENTIONS HAVE BEEN REPORTED FOR THIS PATIENT. THE PATIENT EXITED THE CLINICAL STUDY ON (B)(6) 2017.

  Patient problems: No Code Available

  MAUDE report 6412450 ↗