Zenith Flex G55209Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002552095), received between Dec 10, 2014 and Mar 26, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 1 ENDOLEAK PERSISTED AFTER PLACEMENT OF A ZENITH FLEX WITH Z-TRAK AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION. THE PATIENT PRESENTED SYMPTOMATIC FOLLOWING THE IMPLANTATION OF A COOK MAIN BODY GRAFT AND TWO COOK LEG GRAFTS. A LARGE TYPE 1 ENDOLEAK WAS DISCOVERED, RESULTING IN THE PLACEMENT OF A MAIN BODY EXTENSION GRAFT IN A SECONDARY PROCEDURE (WHICH IS THE SUBJECT OF THIS COMPLAINT). FOLLOWING PLACEMENT, THE GRAFT WAS BALLOONED IN THE LEFT RENAL USING A COOK CODA BALLOON INFLATED TO 25 CC. HOWEVER, THE ENDOLEAK STILL REMAINED, SO TEN COMPETITOR SCREWS WERE PLACED AND THE AREA WAS RE-BALLOONED. ULTIMATELY, A COMPETITOR BARE STENT GRAFT WAS PLACED. AFTERWARDS, A "SLIGHT BLUSHING" LEAK WAS STILL PRESENT, BUT THE PHYSICIAN DECIDED TO LEAVE IT AS IS AS THE LEAK HAD "DRASTICALLY IMPROVED". THE PATIENT WAS ON A COUMADIN REGIMEN AND WAS HEPARINIZED DURING THE PROCEDURE. THE PATIENT REMAINED IN THE HOSPITAL BUT WAS SAID TO BE CURRENTLY STABLE AND "DOING WELL". ADDITIONAL INFORMATION REGARDING THE PATIENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. THE INITIAL TYPE 1 ENDOLEAK ON THE COOK MAIN BODY GRAFT IS REPORTED UNDER MDR: 1820334-2020-00696.

  Patient problems: No Code Available

  MAUDE report 9886248 ↗
• MalfunctionDec 10, 2014Leak/Splash

  PER COMPLAINT FORM: THIS VALVE WAS LEAKING BADLY BETWEEN THE CLEAR PLASTIC AND THE VALVE. IT WAS SPRAYING EVERYWHERE. THE PT DID NOT REQUIRE ANY ADD'L PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 4360769 ↗