Zenith TX2 Pro-Form G53422Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002534220), received between Jun 7, 2016 and Jun 7, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• MalfunctionJun 7, 2016Difficult to Remove; Device Operates Differently Than Expected

  DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: A (B)(6) FEMALE PATIENT UNDERWENT A THORACIC ENDOVASCULAR STENT GRAFT PLACEMENT PROCEDURE FOR A THORACIC AORTA DISSECTION FROM LEFT SUBCLAVIAN TO A FEW CM ABOVE CELIAC WITH SMALL ULCERATION. DURING THE PROCEDURE THE PHYSICIAN DEPLOYED THE GRAFT AND WENT TO PULL THE TRIGGER WIRE, THE THUMB SCREW CAME OFF FINE BUT AFTERWARDS THE GREEN TRIGGER WIRE RELEASE MECHANISM WOULD NOT PULL OFF; WE WERE ABOUT TO CUT THE WIRES AND HAVE HIM PULL THEM THAT WAY AFTER CHECKING TO SEE IF THERE WAS SOME TENSION BUILT UP IN THE DEPLOYMENT SYSTEM BUT AFTER A FEW MINUTES HE WAS ABLE TO FINALLY TUG THE TRIGGER WIRE RELEASE MECHANISM OFF WITHOUT HAVING TO CUT ANYTHING. THE STENT GRAFT REMAINED IN THE PATIENT'S BODY AS INTENDED BUT EVERYTHING ELSE WAS REMOVED. 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

  MAUDE report 5702747 ↗