Zenith Flex G48418Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10827002484181), received between Feb 25, 2015 and Jan 16, 2025 — classified as 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2025Difficult to Remove; Difficult to Remove

  IN ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT HAD SOME TORTUOSITY AND ATHEROMA/CALCIFICATION. THE RIGHT COMMON ILIAC ARTERY (CIA) STENT WAS IN-SITU PRIOR TO THE CASE. THE PROXIMAL TOP STENT TRIGGER WIRE WAS RELEASED PRIOR TO ADVANCEMENT OF THE TOP CAP. NO DIFFICULTY WAS EXPERIENCED WITH TOP CAP REMOVAL. IT WAS CONFIRMED THAT THE DISTAL IPSILATERAL LIMB TRIGGER WIRE WAS RELEASED PRIOR TO ADVANCEMENT OF THE TOP CAP. THE IFU WAS FOLLOWED, AND ALL TRIGGER WIRES WERE REMOVED. NO TENSION WAS FELT. ONLY ONCE THE DILATOR TIP WAS COMING DOWN INTO THE DISTAL AORTA/ILIACS WAS IT NOTICED THAT THE CANNULA AND DILATOR WERE SEPARATING. THE PIN VISE WAS CHECKED AGAIN TO MAKE SURE THAT IT WAS SECURE, AND IT DID NOT APPEAR TO BE LOOSE. WHEN TRYING TO REMOVE THE SYSTEM THROUGH THE SHEATH, THE SEPARATION WAS CONTINUED AND COULD NOT BE REMOVED. A SHORT 18F SHEATH WAS PREPARED AND A SHEATH EXCHANGE WAS MADE. THE DEVICE WAS REMOVED COMPLETELY, WITH THE SHEATH AND DILATOR/CANNULA STILL INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170735 ↗
• InjuryJul 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 3 ENDOLEAK WAS IDENTIFIED IN A (B)(6) PATIENT THAT HAD A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY IMPLANTED. THE THEN (B)(6) PATIENT WAS DIAGNOSED WITH AN INFRA-RENAL ABDOMINAL AORTIC ANEURYSM (DIAMETER: 6.7X 6.4CM, LENGTH: 6.7X 6.4CM) AND UNDERWENT AN ENDOVASCULAR ABDOMINAL AORTIC REPAIR (EVAR) PROCEDURE ON (B)(6) 2013, IN WHICH THE FOLLOWING DEVICES WERE IMPLANTED: COOK ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY RPN: TFFB-28-96-ZT, LOT: 3812613. COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-13-56-ZT, LOT: 3984758 (IPSILATERAL ILIAC LEG). COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG RPN: ZSLE-16-90-ZT, LOT: 3781834 (CONTRALATERAL ILIAC LEG). DURING THE INDEX PROCEDURE, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA IN THE SUPINE POSITION. SKIN INCISIONS WERE MADE ON BOTH GROINS AND AN APPROACH WAS MADE TO THE FEMORAL ARTERY. THE GUIDE WAS INSERTED UNDER FLUOROSCOPY, THE PLASTIC SHEATH WAS INSERTED, AND CONTRAST MEDIA WAS INJECTED, THE MAIN BODY GRAFT (TFFB-28-96-ZT) WAS INSERTED INTO THE LEFT GROIN, FOLLOWED BY THE EXTENSION ILIAC LEGS (ZSLE-13-56-ZT AND ZS

  Patient problems: Clinical Endoleak

  MAUDE report 17334257 ↗
• InjuryJan 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED ENDOLEAKS OCCURRED AFTER THE IMPLANTATION OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY AND A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. A 73-YEAR-OLD MALE PATIENT HAD THREE GRAFTS IMPLANTED ON (B)(6) 2013. DURING A ROUTINE FOLLOW-UP COMPUTED TOMOGRAPHY SCAN, THE PHYSICIAN DISCOVERED A TYPE 1A ENDOLEAK AT THE MAIN BODY GRAFT AND A TYPE 1B ENDOLEAK AT THE LEFT ILIAC GRAFT. THE PHYSICIAN IS PLANNING TO PERFORM A FENESTRATED GRAFT REPAIR. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. THIS REPORT COVERS THE TYPE 1A ENDOLEAK AT THE MAIN BODY GRAFT. THE TYPE 1B ENDOLEAK AT THE LEFT ILIAC GRAFT IS COVERED UNDER ANOTHER REPORT WITH PATIENT IDENTIFIER: (B)(6). ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 16087428 ↗
• InjuryApr 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A TYPE 3 ENDOLEAK OCCURRED ON A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY FOLLOWING AN EMERGENCY ENDOVASCULAR AORTIC ANEURYSM REPAIR PROCEDURE. DURING THE INDEX PROCEDURE ON (B)(6) 2018, THE PATIENT RECEIVED FOUR ZENITH ILIAC LEGS OF VARYING SIZES AND ONE ZENITH MAIN BODY DEVICE. ON (B)(6) 2022, IMAGING REVEALED A POSSIBLE TYPE 3 ENDOLEAK NEAR THE BIFURCATION OF THE MAIN BODY DEVICE. THE PHYSICIAN INTENDS ON RELINING THE MAIN BODY AND LEGS, ALTHOUGH A PROCEDURE DATE IS NOT CONFIRMED AT THIS TIME. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 14137876 ↗
• MalfunctionFeb 3, 2021Deformation Due to Compressive Stress; Difficult to Advance; Deformation Due to Compressive Stress; Difficult to Advance

  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 11273960 ↗
• MalfunctionJan 5, 2021Partial Blockage; Partial Blockage

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11120304 ↗
• InjuryMar 26, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT DEVELOPED A TYPE 1 ENDOLEAK AFTER IMPLANTATION OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. FOLLOWING THE INITIAL PROCEDURE, THE PATIENT PRESENTED AS SYMPTOMATIC. AFTER THE DISCOVERY OF A LARGE TYPE 1 ENDOLEAK, THE PATIENT UNDERWENT A SECONDARY PROCEDURE IN WHICH A COOK EXTENSION GRAFT WAS PLACED AND BALLOONING WAS PERFORMED BELOW THE PATIENT'S LEFT RENAL. AT THIS STAGE, THE ENDOLEAK DID NOT RESOLVE, SO TEN COMPETITOR SCREWS WERE PLACED AND THE AREA WAS BALLOONED AGAIN. ULTIMATELY, A COMPETITOR BARE STENT GRAFT WAS PLACED. AFTERWARDS, A "SLIGHT BLUSHING" LEAK WAS STILL NOTED AS THE ENDOLEAK DID NOT COMPLETELY RESOLVE. DURING THE PROCEDURE, THE PATIENT WAS ON A COUMADIN REGIMEN AND WAS HEPARINIZED. THE PATIENT REMAINED IN THE HOSPITAL AND IS SAID TO BE STABLE AND "DOING WELL". ADDITIONAL INFORMATION REGARDING THE PATIENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. MORE DETAILS ON THE SECONDARY PROCEDURE AND THE ENDOLEAK FROM THE ESBE DEVICE ARE REPORTED ON AN MDR WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Code Available

  MAUDE report 9886190 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS DEPLOYED AS INTENDED IN THE TARGET SITE; HOWEVER, THERE WAS A MURAL THROMBUS WHICH PREVENTED THE GRAFT FROM FULLY EXPANDING. UPON ADDITIONAL IMAGING, THE PHYSICIAN DECIDED TO CONVERT TO AN OPEN REPAIR AND REMOVED BOTH OF THE IMPLANTED COOK DEVICES (TFFB-28-96-ZT & ZSLE-16-90-ZT). DURING THE OPEN PROCEDURE THE GRAFT WAS NOT IN A DISSECTION PLANE, BUT WAS IMBEDDED WITHIN THE THROMBUS OF THE ANEURYSM. THE PHYSICIAN DESCRIBED THE INTIMA AS INTACT. THE PHYSICIAN CONFIRMED THE DEVICE WAS WITHIN MURAL THROMBUS WHICH PREVENTED THE DEVICE FROM OPENING. THE OUTCOME OF THE PROCEDURE WAS OVERALL SUCCESSFUL AND THE PATIENT IS STABLE AND DOING WELL.

  Patient problems: No Code Available

  MAUDE report 8279227 ↗
• MalfunctionMar 8, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED A MALE PATIENT WITH AN AORTIC ANEURYSM UNDERWENT AN ENDOVASCULAR ANEURYSM (EVAR) REPAIR ON (B)(6) 2018. THE PHYSICIAN HAS REPORTED A TYPE 4 ENDOLEAK WAS IDENTIFIED ON THE FOLLOW UP ULTRASOUND. THERE WAS THE APPEARANCE OF CONTRAST FROM A SUTURE HOLE IN THE GRAFT. THE PHYSICIAN HAS DISCUSSED RELINING THE GRAFT WITH AN ESBE-28-39 IF NEEDED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AT THIS TIME. WE HAVE REQUESTED TO BE ADVISED IF THE PHYSICIAN DECIDES TO PERFORM A SECONDARY PROCEDURE AS WELL AS AN UPDATE ON THE PATIENT 'S STATUS/OUTCOME.

  Patient problems: No Code Available

  MAUDE report 7324957 ↗
• InjuryAug 29, 2017Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THE PHYSICIAN STATED WHEN THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS INITIALLY IMPLANTED ON (B)(6) 2016, THERE WAS A TYPE 1A ENDOLEAK, HE STATED CALCIFICATION IN THE INFRARENAL SEAL ZONE HAD AFFECTED THE SEAL. HE WAS MONITORING THE ENDOLEAK AND A COUPLE OF MONTHS LATER HE DID A SECONDARY PROCEDURE AND IMPLANTED A COMPETITOR STENT INTO THE PROXIMAL SEAL ZONE OF THE FLEX GRAFT. WHEN HE DID A COMPUTED TOMOGRAPHY (CT) SCAN TO FOLLOW-UP THIS SECONDARY PROCEDURE THE ENDOLEAK WAS STILL EVIDENT AND HE HAS REPORTED THAT THE DISTAL END OF THE COMPETITOR STENT HAS CAUSED A FABRIC TEAR IN THE FLEX GRAFT. HE PLANS TO EXPLANT THIS GRAFT ON (B)(6) 2017 AND RETURN TO COOK FOR EVALUATION. ADDITIONALLY, IT WAS REPORTED THAT HE DID A SECONDARY PROCEDURE WHERE HE ADDED A BARE STENT FROM ANOTHER COMPANY AND PLACED THIS WITHIN THE PROXIMAL END OF THE FLEX GRAFT TO SEE IF THIS IMPROVED THE ENDOLEAK. THE LEAK BECAME WORSE AND IT IS NOW EVIDENT ON CT THAT THE DISTAL END OF THIS BARE STENT HAS CAUSED A FABRIC TEAR IN THE FLEX GRAFT, THEREFORE HE IS PLANNING TO EXPLANT THE GRAFT. PATIENT OUTCOME WAS NOT PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6826748 ↗
• MalfunctionJul 26, 2017Material Integrity Problem

  PRIOR TO PATIENT USE, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS ROUGH AND SLIGHTLY MANGLED UPON OPENING PACKAGE. THE USER ATTEMPTED TO SMOOTH THE DEVICE AND USE IT, BUT RESISTANCE WAS ENCOUNTERED, SO THE DEVICE WAS REMOVED AND THE PROCEDURE CONTINUED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT INJURIES OR ADDITIONAL MEDICAL INTERVENTION REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6743522 ↗
• MalfunctionJul 12, 2017Material Frayed; Physical Resistance

  IT WAS REPORTED THAT THE USER PREPARED THE DEVICE AS USUAL AND INSERTED THE DELIVERY SYSTEM FROM THE RIGHT COMMON FEMORAL ARTERY BUT RESISTANCE WAS MET. HE CHECKED THE SHEATH TIP AND FOUND IT WAS FRAYED. HE REPLACED IT WITH A BACK-UP TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708526 ↗
• MalfunctionJul 12, 2017Leak/Splash

  IT WAS REPORTED THE CAPTOR VALVE LEAKED DURING FLUSHING. THIS DEVICE DID NOT MAKE PATIENT CONTACT AS THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A ANOTHER DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708477 ↗
• InjuryAug 8, 2016Material Separation; Material Separation

  THE INITIAL REPORTER STATES THE BIFURCATED MAIN BODY SHEATH CRASHED WHILE BEING PULLED BACK DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 21JUL2016: THE INNER PART AND THE OUTER PART OF THE SHEATH GOT SEPARATED FROM EACH OTHER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5853958 ↗
• InjuryFeb 25, 2015Leak/Splash

  STENT WAS IMPLANTED ON (B)(6) 2011. NO ISSUES ON THE GRAFT OR THE PT WERE OBSERVED. HOWEVER, A TYPE 1 PROXIMAL ENDOLEAK HAS BEEN OBSERVED AND IT WAS NOTED THAT THE GRAFT IS ACTUALLY LOOSE IN THE AORTA. THE SURGEON PUT IN PLACE A STAIN STENT TYPE PLAMAX. IF IT'S NOT POSSIBLE TO REPAIR WITH A FENESTRATED GRAFT, THE SURGEON WILL THEN RETRIEVE THE MAIN BODY GRAFT ON (B)(6). NO OTHER ISSUES WERE OBSERVED WITH THE PT AND NO ADD'L INFO HAS BEEN PROVIDED.

  Patient problems: Surgical procedure, additional

  MAUDE report 4561890 ↗