Zenith Flex G48435Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002484358), received between May 4, 2016 and Dec 13, 2016 — classified as 3 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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.

• InjuryDec 13, 2016Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING ENDVASCUAR ANEURYSM REPAIR (EVAR) FOR TREATMENT OF ABDOMINAL AORTIC ANEURYSM (AAA) AFTER RELEASING THE TRIGGER WIRE, THE PHYSICIAN TRIED UNSUCCESSFULLY TO REMOVE THE TOP CAP. HE UNDID THE PIN VICE AND HELD THE GREY INTRODUCER STILL AND TRIED AGAIN TO PUSH THE TOP CAP OFF BUT THE INTRODUCER WIRE KEPT BOWING. AFTER NUMEROUS ATTEMPTS, THE TOP CAP EVENTUALLY CAME OFF, HOWEVER, DUE TO THE PUSHING, THE GRAFT HAD MOVED UP AND COVERED THE RIGHT RENAL ARTERY. AS A RESULT, THE PHYSICIAN HAD TO CANNULATE THE RENAL ARTERY TO PLACE A STENT. THE REST OF THE GRAFT WAS DEPLOYED WITHOUT INCIDENT; HOWEVER, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED IMPAIRED RENAL FLOW DUE TO THE GRAFT COVERING THE RIGHT RENAL ARTERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Occlusion

  MAUDE report 6169026 ↗
• InjuryJul 13, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN ABDOMINAL ANEURYSM REPAIR, THE CHECK-FLO HUB LEAKED THROUGHOUT THE PROCEDURE. THE PATIENT EXPERIENCED BLOOD LOSS (APPROXIMATELY 300 TO 400 LITERS). HOWEVER, THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Blood Loss

  MAUDE report 5789655 ↗
• InjuryMay 4, 2016Difficult to Remove; Difficult to Remove

  WHILE PERFORMING A AAA WITH A 36MM X 149MM MAIN BODY GRAFT. THE GRAFT POSITIONED JUST BELOW RIGHT RENAL AND DEPLOYED AS NORMAL UNTIL CONTRALATERAL LIMB OPENED. THE CONTRALATERAL LIMB CANNULATED THEN WENT TO DEPLOY THE SUPRARENAL STENT. THE PROXIMAL TRIGGER WIRE RELEASE WAS UNDONE, BUT UNABLE TO PULL OUT TRIGGER WIRE. AFTER MUCH FORCE THE TRIGGER WIRE PULLED OUT, BUT THIS HAD PULLED THE GRAPH DOWN. THE GRAPH WAS REPOSITIONED TO JUST BELOW THE RIGHT RENAL AGAIN AND THEN TRIED TO DO THE TOP CAP. UNDID THE PIN VICE HELD GREY INTRODUCER STILL AND TRIED TO PUSH THE TOP CAP OFF BUT THE INTRODUCER WIRE KEPT BOWING AND TOP CAP WOULD NOT COME OFF. THE PHYSICIAN TRIED A NUMBER OF TIMES AND EVENTUALLY THE TOP CAP CAME OFF, BUT WITH ALL THE PUSHING IT HAD PUSHED THE GRAFT UP AND COVERED THE RIGHT RENAL. THE PHYSICIAN HAD TO THEN CANNULATE THE RENAL AND PLACE A STENT INTO THE RIGHT RENAL. THE REST OF THE GRAFT WAS DEPLOYED WITHOUT INCIDENCE. THE PATIENT DID NOT REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE, HOWEVER SHE DID REQUIRE A RENAL STENT TO BE PLACED INTO R) RENAL AS THE GRAFT HAD JUMPED FORWARD WITH ALL THE FORCE TO GET THE TOP CAP OFF. ADVERSE EFFECT TO THE PATIENT AS A RESULT

  Patient problems: No Code Available; Occlusion

  MAUDE report 5631183 ↗