Zenith TX2 Pro-Form G53451Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002534510), received between May 27, 2016 and Apr 16, 2020 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  DESCRIPTION OF EVENT ACCORDING TO STUDY: GRAFT KINK. ON (B)(6) 2015, THE PATIENT RECEIVED A ZTEG-2PT-40-208-PF-US. 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 AND ANALYSIS, THE DEVICE WAS PATENT WITH NO KINK OR ENDOLEAK ON THE COMPLETION ANGIOGRAM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015 (THREE DAYS POST-PROCEDURE). (B)(6) 2015 CT SCAN (40 DAYS POST-PROCEDURE): ANALYSIS: GRAFT PATENT AND INTACT WITH NO KINK OR ENDOLEAK. ANEURYSM DIAMETER = 77.7 MM. (B)(6) 2015 CT SCAN (185 DAYS POST-PROCEDURE): ANALYSIS: GRAFT PATENT AND INTACT WITH NO MIGRATION, KINK, OR ENDOLEAK. ANEURYSM DIAMETER = 67.9 MM. ANALYSIS ALSO NOTED < 1 CM DISTAL SEAL ZONE. (B)(6) 2016 CT SCAN (381 DAYS POST-PROCEDURE): CRANIAL MIGRATION AND UNKNOWN ENDOLEAK ((B)(4)). (B)(6) 2020 ANALYSIS REVIEW OF A CT PERFORMED ON (B)(6) 2019 REVEALED A PATENT AND INTACT GRAFT WITH NO ENDOLEAK PRESENT. A KINK WAS IDENTIFIED AND THE LOCATION WAS NOTED AS, ¿DISTAL AORTIC ARCH/PROXIMAL DESCENDING THORACIC AORTA.¿ ANALYSIS ALSO NOTED THE FOLLOWING, ¿AT 48 MONTHS, THERE WAS VERY EARLY NARROWING OF THE DE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Consequences Or Impact To Patient

  MAUDE report 9966547 ↗
• DeathAug 28, 2017Flaked; Flaked

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "ON A MEETING ON MONDAY, PHYSICIAN INDICATED HE HAD A PATIENT THAT UNDERWENT A PROCEDURE AND DIED A FEW DAYS POST OP FROM MULTI-ORGAN FAILURE. AUTOPSY DETERMINED SOME OF THE HYDROPHILLIC COATING IN THE ORGANS, ASSUMED FROM THE DELIVERY SYSTEM." PATIENT OUTCOME: PT IS DECEASED.

  Patient problems: Cardiac Arrest; Death; Multiple Organ Dysfunction Syndrome; Paraplegia

  MAUDE report 6823343 ↗
• InjuryJul 13, 2016Leak/Splash; Migration or Expulsion of Device; Migration or Expulsion of Device

  DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2015, THE PATIENT RECEIVED A ZTEG-2PT-40-208-PF-US (LOT # E3209058). THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICE. A MOLDING BALLOON WAS NOT USED. NO PATIENT-RELATED ADVERSE EVENTS WERE OBSERVED DURING THE PROCEDURE. THE DEVICE WAS PATENT WITH NO KINK OR ENDOLEAK ON THE COMPLETION ANGIOGRAM. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015 (THREE DAYS POST-PROCEDURE). THE (B)(6) 2015 CT SCAN (40 DAYS POST-PROCEDURE): ANALYSIS REVIEW: GRAFT PATENT AND INTACT WITH NO KINK OR ENDOLEAK ANEURYSM DIAMETER = 77.7 MM. THE (B)(6) 2015 CT SCAN (185 DAYS POST-PROCEDURE): ANALYSIS REVIEW: GRAFT PATENT AND INTACT WITH NO MIGRATION, KINK, OR ENDOLEAK. ANEURYSM DIAMETER = 67.9 MM. IT WAS ALSO NOTED < 1 CM DISTAL SEAL ZONE. THE (B)(6) 2016 CT SCAN (381 DAYS POST-PROCEDURE): ANALYSIS REVIEW: GRAFT PATENT AND INTACT WITH NO MIGRATION OR KINK. A DISTAL TYPE I ENDOLEAK WAS NOTED. ANEURYSM DIAMETER = 63.8 MM. ANALYSIS MADE THE FOLLOWING COMMENT: ¿THE DISTAL SEAL MAY BE COMPROMISED BY AN INCREASE IN AORTA DIAMETER. THERE IS A SEGMENT OF SEAL AT THE MID-GRAFT LEVEL, EXTENDING JUST UNDER 10MM, THAT APPEARS TO BE ALLOWING THE PRIMARY PORTION

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

  MAUDE report 5788637 ↗
• MalfunctionMay 27, 2016Break; Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: UPON DEPLOYMENT, IT WAS VERY DIFFICULT TO RELEASE THE TRIGGER WIRES. WIRES WERE ABLE TO BE RELEASED INDIVIDUALLY WITH HEMOSTAT. DUE TO MANIPULATION REQUIRED ONE OF THE NITINOL WIRES BROKE. ULTIMATELY, THE PROCEDURE WAS SUCCESSFUL AND THE DEVICE WAS PLACED IN THE PATIENT. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5684257 ↗