Zenith TX2 Pro-Form G53479Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002534794), received between Jun 25, 2018 and Jun 25, 2018 — classified as 1 death.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.

• 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 COMPONENT IMPLANTED AS PROXIMAL EXTENSION, (B)(6) 2014, ZTA IMPLANTED FOR SEPARATION, UNKNOWN DATE. 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 7633029 ↗