Zenith TX2 Pro-Form G53428Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002534282), received between Mar 9, 2016 and Mar 7, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2022Off-Label Use; Off-Label Use

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PER IMAGING FINDINGS UNDER (B)(4) (MANUFACTURE REF# 3002808486-2021-01887) ADDITIONAL COMPLAINT LOGGED TO COVER FOR KINK IN PROXIMAL END OF TX2: THE PHYSICIAN WAS TRYING TO DEDUCE THIS FROM THE PRE-OP IMAGING WHICH WAS DONE ON (B)(6) 2015, THE PATIENT APPEARS TO HAVE HAD A PRIOR SURGICAL ARCH RECONSTRUCTION, INCLUDING AN AORTIC VALVE REPLACEMENT. THERE HAS BEEN DEBRANCHING OF THE ARCH BRANCHES, SO THAT THEY ALL ARISE FROM A SINGLE TRUNK, THE DISTAL END OF THE SURGICAL GRAFT LOOKS TO HAVE AN ANGULATION OF ABOUT 90 DEGREES, AND INCLUDES A MARKED KINK ON THE INNER CURVE OF THAT ANGULATION. IMMEDIATELY DISTAL TO THE SURGICAL GRAFT IS A LARGE THORACOABDOMINAL ANEURYSM OF JUST OVER 60MM DIAMETER.¿ NEXT IMAGES ARE FROM (B)(6) 2016 ¿ 1 WEEK POST-PROCEDURE ¿ AND SHOW THE OVERALL SITUATION, WITH A 2-STENT OVERLAP BETWEEN THE TX2 AND THE ALPHA GRAFT IN THE DESCENDING AORTA, AND JUST OVER A 2-STENT OVERLAP BETWEEN THE ALPHA GRAFT AND THE TOP OF THE CMD. IMAGING FROM (B)(6) 2017 ¿ ABOUT 14 MONTHS POST-PROCEDURE ¿ SHOWS THE OVERLAPS ARE STILL IN PLACE, THE KINK IS STILL PRESENT IN THE TX2 GRAFT WHERE IT ¿TURNS THE CORNER¿ INTO THE PREVIOUS SURG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13684521 ↗
• InjuryFeb 23, 2022Off-Label Use; Off-Label Use

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PER IMAGING FINDINGS UNDER (B)(4) (MANUFACTURER REF# 3002808486-2021-01887) ADDITIONAL COMPLAINT LOGGED TO COVER FOR KINK IN PROXIMAL END OF TX2: THE PHYSICIAN WAS TRYING TO DEDUCE THIS FROM THE PRE-OP IMAGING WHICH WAS DONE ON (B)(6) 2015, THE PATIENT APPEARS TO HAVE HAD A PRIOR SURGICAL ARCH RECONSTRUCTION, INCLUDING AN AORTIC VALVE REPLACEMENT. THERE HAS BEEN DEBRANCHING OF THE ARCH BRANCHES, SO THAT THEY ALL ARISE FROM A SINGLE TRUNK, THE DISTAL END OF THE SURGICAL GRAFT LOOKS TO HAVE AN ANGULATION OF ABOUT 90 DEGREES, AND INCLUDES A MARKED KINK ON THE INNER CURVE OF THAT ANGULATION. IMMEDIATELY DISTAL TO THE SURGICAL GRAFT IS A LARGE THORACOABDOMINAL ANEURYSM OF JUST OVER 60MM DIAMETER.¿ NEXT IMAGES ARE FROM (B)(6) 2016 ¿ 1 WEEK POST-PROCEDURE ¿ AND SHOW THE OVERALL SITUATION, WITH A 2-STENT OVERLAP BETWEEN THE TX2 AND THE ALPHA GRAFT IN THE DESCENDING AORTA, AND JUST OVER A 2-STENT OVERLAP BETWEEN THE ALPHA GRAFT AND THE TOP OF THE CMD. IMAGING FROM (B)(6) 2017 ¿ ABOUT 14 MONTHS POST-PROCEDURE ¿ SHOWS THE OVERLAPS ARE STILL IN PLACE, THE KINK IS STILL PRESENT IN THE TX2 GRAFT WHERE IT ¿TURNS THE CORNER¿ INTO THE PREVIOUS SUR

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583907 ↗
• InjuryJan 27, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2012 THE PATIENT RECEIVED ONE ZTEG-2P-34-152-PF-US (LOT # E2816614). THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICE. A MOLDING BALLOON WAS NOT USED. 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. ANALYSIS NOTED A PATENT GRAFT WITH NO KINK. AN ENDOLEAK WAS NOTED. ON (B)(6) 2012 CT SCAN (FIVE DAYS POST-PROCEDURE): CORE LAB REVIEW: GRAFT PATENT, INTACT WITH NO KINK OR ENDOLEAK. MAXIMUM ANEURYSM DIAMETER = 62.8 MM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 (SIX DAYS POST-PROCEDURE). ON (B)(6) 2012 CT SCAN (27 DAYS POST-PROCEDURE): ANALYSIS REVIEW: GRAFT PATENT, INTACT WITH NO MIGRATION, KINK, OR ENDOLEAK. MAXIMUM ANEURYSM DIAMETER = 65.4 MM. ON (B)(6) 2012 CT SCAN (148 DAYS POST-PROCEDURE): ANALYSIS REVIEW: GRAFT PATENT, INTACT WITH NO MIGRATION, KINK, OR ENDOLEAK. MAXIMUM ANEURYSM DIAMETER = 62.9 MM. ON (B)(6) 2013 CT SCAN (387 DAYS POST-PROCEDURE): ANALYSIS REVIEW: GRAFT PATENT, INTACT WITH NO MIGRATION, KINK, OR ENDOLEAK. MAXIMUM ANEURYSM DIAMETER = 42.6 MM. ON (B)(6) 2014 CT SCAN (765 DAYS POST-PROCEDURE):

  Patient problems: Aneurysm

  MAUDE report 6282297 ↗
• InjuryMar 9, 2016Leak/Splash

  DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2013, THE PATIENT RECEIVED A ZTEG-2P-34-127-PF-US (LOT # E3137095) AND A ZTEG-2P-34-152-PF-US (LOT # E2921561). THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICE. A MOLDING BALLOON WAS NOT USED. 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 PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013 (SIX DAYS POST-PROCEDURE). ON (B)(6) 2014 CT SCAN (34 DAYS POST-PROCEDURE): GRAFTS PATENT, INTACT WITH NO KINK OR ENDOLEAK. NEW PSEUDOANEURYSMS WERE PRESENT PROXIMAL AND DISTAL TO THE ENDOGRAFT MARGINS. THE PROXIMAL PSEUDOANEURYSM ELIMINATED THE PROXIMAL SEALING ZONE AND THE DISTAL PSEUDOANEURYSM SHORTENED THE DISTAL SEALING ZONE. MAXIMUM ANEURYSM DIAMETER = 50.1 MM. ON (B)(6) 2015 CT SCAN (392 DAYS POST-PROCEDURE): GRAFTS PATENT, INTACT WITH NO MIGRATION OR KINK. A DISTAL TYPE I ENDOLEAK WAS NOTED. MAXIMUM ANEURYSM DIAMETER = 40.6 MM. ON (B)(6) 2015 CT SCAN (740 DAYS POST-PROCEDURE): GRAFTS PATENT, INTACT WITH NO MIGRATION OR KINK. A DISTAL TYPE I ENDOLEAK WAS NOTED. MAXIMUM ANEURYSM DIAMETER = 47.7 MM. PATIENT OUTCOME: ON (B)(6)

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 5488468 ↗