Zenith TX2 Pro-Form G53435Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002534350), received between Dec 13, 2016 and Dec 3, 2019 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2019Fracture; Migration; Fracture; Migration

  DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2014, THE PATIENT RECEIVED A ZTEG-2P-38-202-PF-US (LOT# E3187738) AND A ZTEG-2P-38-152-PF-US (LOT# E31849901). THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICE. A MOLDING BALLOON FROM ANOTHER MANUFACTURER 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. ANALYSIS NOTED A PATENT GRAFT WITH NO KINK. A POSSIBLE ENDOLEAK WAS NOTED AT THE OVERLAP OF THE TWO DEVICES AND AT THE MID/DISTAL ASPECT OF THE DISTAL COMPONENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 (FOUR DAYS POST-PROCEDURE). (B)(6) 2014 NON-CONTRAST CT SCAN (65 DAYS POST-PROCEDURE): ANALYSIS: NO KINK NOTED. ANEURYSM DIAMETER = 67.1 MM. NO OTHER ASSESSMENTS WERE MADE DUE TO NON-CONTRAST EXAM OF POOR QUALITY. (B)(6) 2015 CT SCAN (198 DAYS POST-PROCEDURE): ANALYSIS: GRAFTS PATENT, INTACT WITH NO KINK. A SMALL DISTAL ENDOLEAK OF UNKNOWN ORIGIN WAS NOTED. MAXIMUM ANEURYSM DIAMETER = 59.5 MM. (B)(6) 2015 CT SCAN (366 DAYS POST-PROCEDURE): ANALYSIS: GRAFTS PATENT, INTACT WITH NO MIGRATION OR KINK. AN ENDOLEAK OF UNKNOWN TYPE WAS NOT

  Patient problems: No Information

  MAUDE report 9400637 ↗
• DeathJun 25, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "PATIENT DIED, CAUSE OF DEATH UNKNOWN." TVAR COMPONENTS SEPARATED, ZTA IN (B)(4) IMPLANTED TO REPAIR OR RECONNECT OR MITIGATE THIS. TVAR COMPONENTS HAD SEPARATED AFTER SEVERAL YEARS. ADDITIONAL INFORMATION RECEIVED 12JUN2018: "PATIENT EXPIRED ON (B)(6) 2018. "PATIENT EXPERIENCED SPINAL SHOCK FROM PARAPLEGIA, BUT THIS WAS NOT DEVICE-SPECIFIC OR RELATED. THE PHYSICIAN ASSERTS THAT THE PROCEDURE RESULTED IN THE PARAPLEGIA COMPLICATION, AND THAT IT WAS NOT DEVICE SPECIFIC OR RELATED." "PRODUCT INFORMATION: A) (B)(6) 2011 INDEX TEVAR: ZTEG-2D-34-186-PF-US, LOT E2463077----AND ZTEG-2P-38-202-PF-US, LOT E2776443. B) (B)(6) 2014 TEVAR (PROXIMAL EXTENSION FOR DISEASE PROGRESSION) ZTEG-2P-38-127-PF-US, LOT E3078098" PATIENT OUTCOME: PATIENT IS DECEASED.

  Patient problems: Death; Paraplegia

  MAUDE report 7633027 ↗
• InjuryDec 13, 2016Kinked; Kinked

  DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2014, THE PATIENT RECEIVED A ZTEG-2P-38-202-PF-US (LOT # E3187738) AND A ZTEG-2P-38-152-PF-US (LOT # E31849901). 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. ANALYSIS NOTED A PATENT GRAFT WITH NO KINK. A POSSIBLE ENDOLEAK WAS NOTED AT THE OVERLAP OF THE TWO DEVICES AND AT THE MID/DISTAL ASPECT OF THE DISTAL COMPONENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014 (FOUR DAYS POST-PROCEDURE). ON (B)(6) 2014, NON-CONTRAST CT SCAN (65 DAYS POST-PROCEDURE): ANALYSIS: NO KINK NOTED. ANEURYSM DIAMETER = 67.1 MM. NO OTHER ASSESSMENTS WERE MADE DUE TO NON-CONTRAST EXAM OF POOR QUALITY. ON (B)(6) 2015, CT SCAN (198 DAYS POST-PROCEDURE): ANALYSIS: GRAFTS PATENT, INTACT WITH NO KINK. A SMALL DISTAL ENDOLEAK OF UNKNOWN ORIGIN WAS NOTED. MAXIMUM ANEURYSM DIAMETER = 59.5 MM. ON (B)(6) 2015, CT SCAN (366 DAYS POST-PROCEDURE): ANALYSIS: GRAFTS PATENT, INTACT WITH NO MIGRATION OR KINK. AN ENDOLEAK OF UNKNOWN TYPE WAS NOTED ((B)(4)).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6168726 ↗