Zenith Flex G48429Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002484297), received between Jul 3, 2017 and Jan 2, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE DILATOR OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY GOT STUCK IN THE VALVE DURING AN ABDOMINAL AORTIC ANEURYSM PROCEDURE. THE MAIN BODY WAS REPORTED TO HAVE BEEN DEPLOYED CORRECTLY. WHEN THE PHYSICIAN WENT TO PULL THE DILATOR OUT OF THE SHEATH, THE DILATOR "WOULD NOT COME OUT AS IT WOULD GET STUCK ON THE SHEATH". THE DISTRICT SALES MANAGER WAS PRESENT FOR THE PROCEDURE AND WAS ABLE TO CONFIRM THAT THE DILATOR AND TOP CAP WERE MARRIED TOGETHER PROPERLY. THE PHYSICIAN THEN ATTEMPTED TO RE-ADVANCE THE DEVICE. IT WAS REPORTED THAT THE PHYSICIAN ALSO "SEPARATED THE PIN VICE AND RECAPTURE DTHE TOP CAP TO FORM A SMOOTH TRANSITION AND ONE DILATOR AGAIN." THE DILATOR WAS ATTEMPTED TO BE PULLED OUT AGAIN, BUT GOT STUCK AT THE TIP OF THE CATHETER AFTER THE PEEL-AWAY SHEATH WAS REMOVED. THE DILATOR WAS ADVANCED TO DOC THE TOP CAP, FOLLOWED BY TIGHTENING THE PIN VISE. THE PHYSICIAN "TRIED A LITTLE MORE FORCE- AS MUCH AS WAS COMFORTABLE", BUT ULTIMATELY EXCHANGED THE DEVICE FOR A 20FR SHORT SHEATH AND "WALKED EVERYTHING OUT". THE PROCEDURE WAS COMPLETED SUCCESSFULLY "AS IT SHOULD BE EXPECTED". FOLLOWING THE PROCEDURE, THE PHYSICIAN TESTED THE DEVICE BY U

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9539509 ↗
• MalfunctionApr 24, 2019Difficult or Delayed Activation; Difficult or Delayed Activation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546667 ↗
• MalfunctionJan 16, 2018Device Markings/Labelling Problem; Positioning Problem; Device Markings/Labelling Problem; Positioning Problem

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) ON A MALE PATIENT, THERE WAS DIFFICULTY CHECKING THE EXACT POSITION OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY IN THE DELIVERY SYSTEM. THEY WERE UNABLE TO USE THE GOLD MARKER ON THE CONTRALATERAL LIMB TO DETERMINE THE EXACT POSITION OF THE GRAFT IN THE DELIVERY SYSTEM PRIOR TO UNSHEATHING AS THE MARK WAS "U-SHAPED" INSTEAD OF A CHECK-MARK. THEY USED TO ALIGNMENT OF THE TRIGGER WIRE KNOBS AND THE CAPTOR VALVE AS AN APPROXIMATE WAY OF CONFIRMING THE POSITION OF THE GRAFT INSIDE THE DELIVERY SYSTEM. THE PROCEDURE WENT WITHOUT AN ISSUE AND THE USE OF THE OTHER PARTS OF THE DELIVERY SYSTEM WAS SUCCESSFUL. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7197683 ↗
• MalfunctionJul 12, 2017Mechanical Problem

  IT WAS REPORTED THAT "ON PREPPING THE DEVICE THE FLUSH CHAMBER ON THE CAPTOR VALVE WOULDN'T SEAL AND ALL THE HEPRANISED SALINE WAS ON THE PREP TROLLEY." AS A RESULT, THE DEVICE WAS NOT USED ON THE PATIENT. THERE WERE NO KNOWN PATIENT CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708434 ↗
• InjuryJul 3, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING AN INFRARENAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE USING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, EXTRA PROCEDURES WERE NEEDED TO RETRIEVE THE TOP CAP OF THE STENT. IT WAS REPORTED THAT THE PATIENT HAD TORTUOUS ILIACS. THE DEVICE, WHICH WAS NOT MODIFIED IN ANY WAY, WAS INSERTED OVER A LUNDERQUIST WIRE AND DEPLOYED ACCORDING TO IFU. THE TOP CAP WAS REMOVED AND THE SUPRARENAL STENT WAS DEPLOYED WITHOUT PROBLEM. THE CONTRALATERAL LIMB WAS INSERTED AND DEPLOYED WITHOUT PROBLEM. THE DISTAL TRIGGER WIRE WAS REMOVED AND COMPLETELY INTACT UPON REMOVAL. TO RETRIEVE THE TOP CAP, THE GREY PUSHER WAS PUSHED UP THE AORTA BUT WAS UNABLE TO BE INSERTED INTO THE IPSILATERAL MAIN BODY PAST THE DISTAL BODY STENT. AN ATTEMPT WAS THEN MADE TO PULL DOWN THE TOP CAP HOWEVER, IT WAS ONLY ABLE TO BE PULLED THROUGH THE BODY TO THE TOP OF THE IPSI-LATERAL MAIN BODY. IT APPEARED IMPOSSIBLE TO RETRIEVE THE TOP. A BALLOON WAS PLACED THROUGH THE IPSILATERAL SHEATH AND THE DISTAL END OF THE TOP CAP WAS CANNULATED WITH THE BALLOON,. THE BALLOON WAS THEN INFLATED ALLOWING THE TOP CAP TO BE PULLED THROUGH THE IPSILATERAL BODY WITHOUT PROBLEM. THE TEAM THEORIZED

  Patient problems: No Code Available

  MAUDE report 6684351 ↗