Zenith TX2 Pro-Form G53480Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002534800), received between Sep 21, 2017 and Dec 5, 2018 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2018Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 8132380 ↗
• DeathSep 21, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  "DESCRIPTION" OF EVENT ACCORDING TO INITIAL REPORTER: "PHONE CALL FROM PHYSICIAN MID PROCEDURE. STATED DISTAL BARE STENT DID NOT DEPLOY UPON SLIDING DOWN OF #2 TRIGGER RELEASE MECHANISM. HE STATED HE REMOVED TRIGGER WIRE NUMBER 1 AND FOLLOWED BY RELEASING AND SLIDING BACK THE DISTAL BARE SPRING DEPLOYMENT MECHANISM WHICH CLICKED IN TO PLACE. HE THEN REMOVED THE #3 TRIGGER WIRE. IT WASN¿T UNTIL AFTER THE #3 TRIGGER WIRE WAS REMOVED THAT HE NOTICED ON THE FLUORO SCREEN THAT THE DISTAL BARE STENT OF THE DISTAL THORACIC GRAFT WAS ONLY HALFWAY DEPLOYED WITH HALF OF THE STENT REMAINING IN THE BOTTOM CAP. HE COULD NOT FURTHER DEPLOY THE BARE STENT AS THE #2 SLIDE MECHANISM WAS ALREADY CLICKED IN TO PLACE. PULLING THE ENTIRE SHEATH AND GREY POSITIONER DOWN AS ONE DID NOT RELEASE THE BARE SPRING. ULTIMATELY HE HAD TO RESHEATH THE BARE STENT BOTTOM CAP AND PUSH AND ROTATE THE GRAY POSITIONER WHICH FINALLY FREED THE BARE STENT AND ALLOWED IT TO FULLY DEPLOY." ADDITIONAL INFORMATION RECEIVED 07SEP2017: "THE PATIENT CAME IN WITH A RUPTURED THORACIC ANEURYSM AND FROM SPEAKING WITH PHYSICIAN LOST TOO MUCH BLOOD DESPITE THEM FINISHING THE PROCEDURE WHICH WAS THE CAUSE OF DEATH." PATIENT OUTCOME: A

  Patient problems: Death

  MAUDE report 6881842 ↗