Zenith Flex G48417Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10827002484174), received between Jan 9, 2015 and Apr 28, 2022 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED A TYPE 3 ENDOLEAK OCCURRED ON A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY FOLLOWING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. DURING THE INDEX PROCEDURE ON (B)(6) 2022, THE PATIENT RECEIVED A ZENITH MAIN BODY DEVICE, TWO ILIAC LEG GRAFTS, AND TWO EXTENSION GRAFTS. COMPLETION ANGIOGRAPHY CONFIRMED NO ENDOLEAKS AND AN ANEURYSMAL SAC OF 58MM IN DIAMETER. ON (B)(6) 2021, ONE MONTH POST-IMPLANTATION, A CT SCAN REVEALED A POSSIBLE TYPE 2 ENDOLEAK AND AN INCREASED ANEURYSMAL SAC, NOW 60MM IN DIAMETER. ON (B)(6) 2021, 6 MONTHS POST-IMPLANTATION, A CT SCAN REVEALED CONTINUED ANEURYSM ENLARGEMENT, NOW 61MM IN DIAMETER. ON (B)(6) 2022, ONE YEAR POST-IMPLANTATION, A CT SCAN REVEALED A TYPE 3 ENDOLEAK POSSIBLY DUE TO A MATERIAL DEFECT. ON (B)(6) 2022, A 3D SCAN CONFIRMED A TYPE 3 ENDOLEAK THROUGH A RUPTURE BETWEEN THE SECOND AND THIRD STENTS ON THE MAIN BODY DEVICE. THE PHYSICIAN INTENDS ON TREATING THE TYPE 3 ENDOLEAK WITH PLACEMENT OF AN EXTENSION GRAFT. AT THIS TIME, THERE IS NO CONFIRMED DATE FOR A SECONDARY PROCEDURE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 14240052 ↗
• InjuryFeb 23, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THE DELIVERY SYSTEM OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS DIFFICULT TO ADVANCE THROUGH THE ARTERIES DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE PHYSICIAN ADMINISTERED CONSIDERABLE FORCE AND THE DELIVERY SYSTEM STILL FAILED TO ADVANCE. THE PROCEDURE WAS ABORTED. A CUT-DOWN WAS PERFORMED ON BOTH SIDES TO CLOSE THE VESSELS. HEPARIN WAS USED DURING THE PROCEDURE. NECK ANATOMY WAS DESCRIBED AS PARALLEL. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588052 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13011362 ↗
• InjuryJul 22, 2019Migration; Migration

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

  Patient problems: No Code Available

  MAUDE report 8813159 ↗
• InjuryMar 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THERE IS NO NEW EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8448058 ↗
• InjuryDec 6, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED, THE INITIAL AORTA-GRAM SHOWED SIGNIFICANT CALCIFICATION IN THE MID AORTA. DURING THE EVAR IN THE ABDOMINAL AORTA, THEY IMPLANTED THREE PIECES. DUE TO CALCIFICATION THERE WERE DIFFICULTIES ADVANCING AND RETRACTING THE DILATOR FROM THE ARTERY. BALLOONS WERE USED ON BOTH SIDES TO RETRACT THE DILATOR. ONCE ALL THREE PIECES WERE IMPLANTED, THERE APPEARED TO BE AN ENDOLEAK PRESENT IN THE FINAL RUN. IMMEDIATELY AFTER THE FINAL RUN THEY OBLIQUED THE C-ARM AND TOOK PICTURE IN VARIOUS PROJECTIONS. THE PHYSICIAN BELIEVED THAT THE GRAFT HAD A HOLE. THE BIFURCATED DEVICE WAS RELINED WITH ANOTHER SHORTER BIFURCATED DEVICE (ZFEN DISTAL BODY). THE SURGEON MODIFIED THE ZFEN DISTAL BODY SO THAT IT WAS SHORT ENOUGH TO LAND INSIDE THE IMPLANTED MAIN BODY. THEY BRIDGED LIMBS FROM THE BIFURCATED DEVICE INTO THE ORIGINAL TFFB THAT WAS PLACED. AT THE CONCLUSION OF THE PROCEDURE THE PATIENT'S ANEURYSM WAS EXCLUDED AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: No Code Available

  MAUDE report 8139843 ↗
• InjuryJul 17, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED A (B)(6) MALE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE USING A COOK ZENITH AND ANOTHER MANUFACTURER'S GRAFT. THE DELIVERY SYSTEM OF A MAIN BODY (TFFB-28-82-ZT) WAS INSERTED FROM THE RIGHT AND PLACED THE MAIN BODY AS LABELED. THEN TWO LEG GRAFTS FROM ANOTHER MANUFACTURER WERE PLACED IN THE RIGHT AND LEFT ILIAC ARTERIES. AN ENDOLEAK WAS CONFIRMED BY THE FINAL ANGIO AND THE PHYSICIAN DETERMINED IT TO BE A PROXIMAL TYPE I ENDOLEAK AND PLACED A CUFF FROM ANOTHER MANUFACTURER. HOWEVER, THE ENDOLEAK WAS NOT RESOLVED SO ADDITIONAL BALLOONING WAS PERFORMED. THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN DID AN ANGIOGRAPHY IN THE MAIN BODY AND CONFIRMED THE LOCATION OF THE ENDOLEAK. IT COULD BE A TYPE III OR TYPE IV ENDOLEAK BUT MORE LIKELY TO BE TYPE III (DAMAGE IN GRAFT) FROM HOW IT APPEARED. THE PHYSICIAN DECIDED NOT TO DO FURTHER TREATMENT FOR THE ENDOLEAK AND TAKE A WAIT-AND-SEE APPROACH AND COMPLETED THE PROCEDURE. THERE IS NO INFORMATION THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE AS THE DATE OF THIS REPORT.

  Patient problems: No Code Available

  MAUDE report 7694266 ↗
• InjuryJul 9, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED AN (B)(6) FEMALE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) PREVIOUSLY UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE VIA FEMORAL ACCESS ON (B)(6) 2017. THE PATIENT WAS TREATED USING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. A TYPE 1A ENDOLEAK WAS DISCOVERED AND THE PATIENT WAS BROUGHT IN FOR SECONDARY INTERVENTION TO REPAIR THE LEAK. ADDITIONALLY, THE ANEURYSM SAC WAS ENLARGED FROM THE TYPE 1A ENDOLEAK. DURING THE SECONDARY INTERVENTION PERFORMED ON (B)(6) 2018, THE PATIENT WAS TREATED WITH PERCLOSE DEVICES FOR ACCESS IN BOTH FEMORAL ARTERIES. SHEATHS WERE USED TO ACCESS THE FEMORAL ARTERIES AND WIRES WERE PLACED. LUNDERQUIST EXTRA STIFF WIRE GUIDES WERE USED. THE PATIENT WAS THEN TREATED WITH A 32MM CODA BALLOON AND ENDOSCREWS. APPROXIMATELY 19 SCREWS WERE PLACED AND THE GRAFT WAS BALLOONED. THE SCREWS WERE PLACED WITH THE ASSISTANCE OF AN IVUS CATHETER. AFTER THE SCREWS WERE PLACED, IT SEEMED TO EXPAND OUT THE GRAFT BUT IT ALSO SEEMED TO PUT A SMALL TEAR IN THE GRAFT. AN ESBE-32-39-ZT WAS PLACED TO COVER THE TEAR. THE CUFF WAS THEN BALLOONED WITH THE 32MM CODA BALLOON AND THEN A FINAL ANGIOGRAPHY WAS DONE. NO LEAK WAS NOTED AND I

  Patient problems: No Code Available

  MAUDE report 7671825 ↗
• MalfunctionNov 8, 2017Positioning Failure; Device Operates Differently Than Expected; Positioning Failure; Device Operates Differently Than Expected

  THE USER FACILITY IN (B)(6) REPORTED THE (B)(6) MALE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). SINCE THERE WAS AN ANEURYSM IN THE RIGHT COMMON ILIAC ARTERY (CIA), THE RIGHT ILIAC ARTERY ANEURYSM (IIA) WAS EMBOLIZED WITH COILS PRIOR TO THE STENT GRAFT PLACEMENT. AFTER THE EMBOLIZATION OF THE RIGHT IIA WAS COMPLETED, ANGIOGRAPHY WAS CONDUCTED WITH A PIG-TAIL CATHETER WITH MARKERS (DEVICE UNKNOWN) AND THE DISTANCE OF THE AREA BETWEEN THE INFERIOR RENAL ARTERY (RA) AND THE TERMINAL AORTA WAS MEASURED. TAKING THE RESULT OF THE MEASUREMENT INTO THE CONSIDERATION, THE PHYSICIAN DETERMINED TO PLACE A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY IN THE PATIENT. AFTER FLUSHING THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, THE DELIVERY SYSTEM WAS ADVANCED TO THE TARGET SITE. THEN, THE PHYSICIAN ATTEMPTED TO WITHDRAW THE SHEATH BACK TO DEPLOY THE STENT GRAFT. HOWEVER, THE SHEATH WAS TOO STIFF AND DIFFICULT TO PULL BACK. THE PHYSICIAN CONTINUED TRYING TO WITHDRAW THE SHEATH BACK FOR APPROXIMATELY 10 MINUTES, BUT IT COULD NOT BE PULLED BACK AT ALL, AND THE STENT GRAFT COULD NOT BE DEPLOYED. ANOTHER ZENITH FLEX

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7010632 ↗
• MalfunctionJul 18, 2017Unintended Movement

  DURING THE PROCEDURE TO PLACE THE STENT , THE USER ATTEMPTED TO WITHDRAW THE INNER CANNULA THROUGH THE SHEATH. THE LOCKING MECHANISM THEN MALFUNCTIONED CAUSING THE WHEEL TO TURN WITHOUT OPENING THE VALVE. THE WHEEL COULD BE TURNED 360 DEGREES WITHOUT STOPPING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT ISSUE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. 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 Known Impact Or Consequence To Patient

  MAUDE report 6723031 ↗
• InjuryFeb 28, 2017Hole In Material; Leak/Splash; Defective Device; Hole In Material; Leak/Splash; Defective Device

  THE CUSTOMER REPORTED THAT THE PATIENT HAD ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY PLACED IN 2010. THAT PATIENT PRESENTED WITH A RUPTURED ANEURYSM. BOTH A COMPUTERIZED TOMOGRAPHIC ANGIOGRAPHY (CTA) AND DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WERE PERFORMED ON THE ARRIVAL OF THE PATIENT. THE NEW CTA SHOWED THE ANEURYSM SAC HAD INCREASED TO 8-9 CENTIMETERS WITH A RUPTURE. THE CUSTOMER STATED THAT THERE WAS INDICATION OF A FABRIC DEFECT IN THE GAP BETWEEN THE SECOND AND THIRD STENTS. THE CUSTOMER FURTHER REPORTED THAT THE PATIENT HAD HIS YEARLY FOLLOW-UP AND SCAN 4 WEEKS PREVIOUSLY. AT THAT TIME THE SCAN SHOWED HIS ANEURYSM WAS STABLE AT 6 CENTIMETERS. THE GRAFT WAS RELINED WITH A ZENITH FLEX® AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION. ANOTHER CTA SHOWED THE LEAK WAS NO LONGER EVIDENT. THE IMAGING HAS BEEN REQUESTED FOR REVIEW BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: No Code Available; Rupture

  MAUDE report 6364961 ↗
• InjuryNov 17, 2016Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AAA REPAIR, THE MAIN BODY GRAFT WAS PLACED ON THE WIRE GUIDE AND DEPLOYED WITHIN THE BODY OF THE (B)(6) MALE PATIENT. AFTER THE MAIN BODY WAS DEPLOYED AND THE GREY POSITIONER/DILATOR WAS REMOVED, THE HEMOSTATIC VALVE CONTINUED TO LEAK; ALTHOUGH THE VALVE WAS IN THE CLOSED POSITION. INFORMATION WAS PROVIDED THAT THE PATIENT LOST ABOUT 1300CC OF BLOOD. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Blood Loss

  MAUDE report 6109863 ↗
• MalfunctionOct 18, 2016Leak/Splash; Leak/Splash

  INFORMATION WAS PROVIDED THAT A (B)(6) MALE PATIENT WITH A HISTORY OF A LEFT ILIAC ARTERY ANEURYSM UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. AFTER PLACING THE MAIN BODY, THE USER REMOVED THE GRAY POSITIONER FROM THE OUTER SHEATH AND A LARGE AMOUNT OF BLOOD LEAKED FROM THE HEMOSTATIC VALVE. THE PHYSICIAN TURNED THE CAPTOR ROTATOR TO CLOSE, BUT BLOOD STILL LEAKED. THEREFORE, THE PHYSICIAN HAD TO REPLACE THE SHEATH WITH ANOTHER MANUFACTURER'S SHEATH. TWO ILIAC LEG GRAFTS WERE IMPLANTED AFTER REPLACING THE SHEATH AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEMS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6036681 ↗
• InjuryJan 9, 2015Leak/Splash

  THE DELIVERY SYSTEM IS PLACED AS USUAL, BUT DURING THE PROCEDURE THE HEMOSTATIC VALVE IS BLEEDING TOO MUCH BLOOD. WHEN THE GRAFT IS GOING TO BE RELEASED THE BLEEDING DOES NOT STOP AND OPPOSITE TO THIS THE BLEEDING INCREASED CONSIDERABLY. 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: Blood Loss

  MAUDE report 4417136 ↗