Zenith Flex G48407Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10827002484075), received between Apr 13, 2016 and Mar 14, 2024 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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.

• MalfunctionMar 14, 2024Difficult to Remove; Difficult to Remove

  ADDITIONAL INFORMATION WAS PROVIDED ON 18MAR2024 INDICATING THAT THE PATIENT'S ILIAC ARTERIES WERE NOT TORTUOUS. AS REPORTED, THE PATIENT DID NOT HAVE PRE-EXISTING CONDITIONS OR COMORBIDITIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904787 ↗
• InjuryJun 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: Clinical Endoleak

  MAUDE report 17085511 ↗
• InjuryApr 15, 2022Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE STENT OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY SEPARATED FROM THE GRAFT MATERIAL DURING AN ENDOVASCULAR AORTIC ANEURYSM REPAIR PROCEDURE. THE SEPARATION WAS NOTED AFTER THE MAIN BODY GRAFT WAS DEPLOYED AND CONNECTED TO THE CONTRALATERAL ILIAC LEG GRAFT. THE IPSILATERAL LEG GRAFT WAS NOT DEPLOYED WHEN THE BREAKAGE WAS NOTED. IT WAS REPORTED THAT NO DIFFICULTY WAS EXPERIENCED WHEN REMOVING THE TOP CAP AND THE DISTAL/IPSILATERAL LIMB TRIGGER WAS NOT RELEASED PRIOR TO ADVANCEMENT OF THE TOP CAP. THE PATIENT UNDERWENT A LAPAROTOMY TO REMOVE THE DEVICE. THE PATIENT STAYED IN THE ICU FOR ONE WEEK AND WAS DISCHARGED AFTER RETURNING TO THE GENERAL WARD FOR ONE WEEK. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118112 ↗
• InjuryFeb 7, 2020Complete Blockage; Complete Blockage

  NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH FORM WAS SENT.

  Patient problems: No Code Available; Thrombus

  MAUDE report 9683778 ↗
• InjuryDec 3, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT DECEASED 1-2 DAYS AFTER THE PROCEDURE DUE TO "OTHER COMPLICATIONS".

  Patient problems: No Code Available

  MAUDE report 9405811 ↗
• InjuryMay 22, 2019Leak/Splash; Leak/Splash

  ON 28MAY2019 ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE PROXIMAL NECK ANATOMY WAS 50MM. THE SHAPE OF THE NECK ANATOMY WAS SUITABLE FOR THE PROCEDURE. IN THE PROCEDURE A CODA BALLOON WAS USED WITHOUT AN INSUFFLATOR. THE INFLATION VOLUME WAS REPORTEDLY APPROPRIATE ACCORDING TO THE PHYSICIAN'S SENSE OF TOUCH. BALLOONING WAS DONE IN 5 PLACES IN TOTAL: THE PROXIMAL SITE, THE JOINTS IN BOTH THE RIGHT AND LEFT SIDE, THE DISTAL SITES. THERE WAS CALCIFICATION AT THE LEFT COMMON ILIAC ARTERY (CIA.) THERE WAS NO SIGNIFICANTLY TORTUOUS ANATOMY.

  Patient problems: No Code Available

  MAUDE report 8633825 ↗
• InjuryMar 22, 2018Hole In Material; Hole In Material

  IT WAS REPORTED THE PATIENT WITH ABDOMINAL AORTIC ANEURYSM (AAA) WAS IMPLANTED WITH A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (TFFB-24-82-ZT). A FABRIC TEAR IN THE MAIN BODY WAS FOUND ON THE FINAL ANGIOGRAPHY. THEREFORE, THE GRAFT WAS RELINED WITH A SHORT ZENITH FENESTRATED DISTAL BODY TO MAINTAIN A BIFURCATED BODY FOR THE PATIENT. THE LEAK WAS SEALED, ALL GRAFTS REMAINED IN THE PATIENT, AND NO ADVERSE EVENTS OCCURRED. THE PATIENT WENT HOME THE NEXT DAY.

  Patient problems: No Code Available

  MAUDE report 7361523 ↗
• InjuryOct 5, 2017Leak/Splash; Leak/Splash

  A (B)(6)-YEAR OLD MALE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) UNDERWENT AAA REPAIR. NO NOTABLE ANATOMICAL PROBLEM SUCH AS CALCIFICATION OR TORTUOUS ANATOMY WERE OBSERVED. A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS INSERTED FROM THE LEFT FEMORAL AND PLACED RIGHT BELOW THE RENAL ARTERIES. ANOTHER MANUFACTURER'S DEVICE WAS PLACED TO RIGHT ABOVE THE INTERNAL ILIAC ARTERY IN THE CONTRALATERAL SIDE THROUGH THE OTHER MANUFACTURER'S 14FR SHEATH. AFTER DEPLOYING THE IPSILATERAL LIMB OF THE MAIN BODY, THE DELIVERY SYSTEM WAS REMOVED AND ANOTHER MANUFACTURER'S 18FR SHEATH WAS INSERTED AND THE OTHER MANUFACTURER'S DEVICE WAS PLACED RIGHT ABOVE THE INTERNAL ILIAC ARTERY. TOUCH-UP BALLOONING WAS PERFORMED USING CODA-10.0-35-100-32, AND ANGIOGRAPHY WAS PERFORMED. TYPE III ENDOLEAK FROM THE DISTAL EDGE OF THE THIRD STENT AND TYPE IB ENDOLEAK FROM THE IPSILATERAL LEG WERE FOUND. ANOTHER MANUFACTURER'S DEVICE WAS PLACED TO TREAT THE TYPE IB ENDOLEAK. THE PHYSICIAN CONFIRMED THE TYPE III ENDOLEAK AGAIN PERFORMING ANGIOGRAPHY FROM THE SHEATH IN THE IPSILATERAL SIDE AND THE ANGIOGRAPHY INSIDE THE MAIN BODY. THE LEAK HAD THE SAME 'BLOWING-OFF' APPEARANCE AT THE SAME LOCATION

  Patient problems: No Code Available

  MAUDE report 6915167 ↗
• InjuryJun 15, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR PROCEDURE WITH A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY AND TWO ILIAC LEG GRAFTS. THE ACCESS VESSEL OF THE MAIN BODY (LEFT) HAD NO CALCIFICATION BUT IT WAS THIN. HOWEVER, IT WAS THICK ENOUGH TO ADVANCE THE DELIVERY SYSTEM OF THE MAIN BODY. THE PROXIMAL NECK WAS STRAIGHT, 20MM AND LONG ENOUGH BUT A PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED, THEREFORE ADDITIONAL BALLOONING WAS PERFORMED. THE ENDOLEAK WAS NOT RESOLVED, SO THE PHYSICIAN DECIDED TO PLACE AN EXTENSION. THE DELIVERY SYSTEM OF THE EXTENSION WOULD NOT ADVANCE TO THE TARGET SITE FROM THE LEFT SIDE. HE TRIED THE RIGHT SIDE WHICH WAS THINNER, BUT THAT ALSO FAILED. ADDITIONAL BALLOONING REDUCED THE ENDOLEAK BUT IT WAS NOT COMPLETELY RESOLVED. WITH NO OTHER OPTIONS, THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE AND TAKE A WAIT AND SEE APPROACH. THE PHYSICIAN CONFIRMED THAT THE PROXIMAL TYPE I ENDOLEAK WAS GONE BY FOLLOW-UP CT PERFORMED ON (B)(6) 2017. NO ADDITIONAL PROCEDURE WAS NEEDED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Code Available

  MAUDE report 6645395 ↗
• MalfunctionMar 31, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE REPAIR OF AN ABDOMINAL AORTIC ANEURYSM (AAA) ON THE (B)(6) MALE PATIENT, USING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, THE VALVE ON THE SHEATH LEAKED THROUGHOUT THE DURATION OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE COMPLAINT DEVICE; HOWEVER, THERE WAS SOME BLOOD LOSS DURING THE PROCEDURE, ALTHOUGH THE EXACT AMOUNT OF BLOOD LOSS COULD NOT BE DETERMINED.. IT WAS REPORTED THAT THE PATIENT DID NOT REQUIRE ADDITIONAL BLOOD PRODUCTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6450119 ↗
• InjuryDec 27, 2016Leak/Splash; Leak/Splash

  THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 6204608 ↗
• InjurySep 20, 2016Leak/Splash; Leak/Splash

  ON (B)(6) 2016, A (B)(6) FEMALE PATIENT UNDERWENT EVAR FOR AAA. THE PATIENT WAS SUITABLE FOR THE PROCEDURE. THE STENT GRAFT PLACEMENT WAS CONDUCTED AS PLANNED; HOWEVER, THE CONFIRMATORY ANGIOGRAPHY CONFIRMED MASSIVE TYPE IV ENDOLEAK. A ZENITH FLEX AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION (ESBE) WAS ADDITIONALLY PLACED INSIDE THE PREVIOUSLY PLACED STENT GRAFT. THE SECOND CONFIRMATORY ANGIOGRAPHY CONFIRMED THAT THE TYPE IV ENDOLEAK DISAPPEARED. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Code Available

  MAUDE report 5963020 ↗
• InjuryJul 6, 2016Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, A MALE PATIENT HAD UNDERGONE AAA REPAIR BY RIGHT FA APPROACH. THE PATIENT WAS SUITABLE FOR THE PROCEDURE. A MAIN BODY GRAFT VIA RIGHT FA APPROACH (TFFB-24-82-ZT), AN ILIAC LEG GRAFT VIA LEFT FA APPROACH (TFLE-18-90-ZT) AND ANOTHER ILIAC LEG GRAFT VIA RIGHT FA APPROACH (TFLE-16-73-ZT) WERE PLACED IN THE PATIENT. DATE UNKNOWN: GRADUAL ENLARGEMENT OF THE AAA WAS CONFIRMED. HISTORY IS SHOWN BELOW. PRE-PROCEDURE: 48.5MM X 51.5MM. ON 2013: F47.7MM X 52.9MM. ON (B)(6) 2015: F51.7MM X 54.8MM. ON (B)(6) 2015:F53.0MM X 55.3MM. ON (B)(6) 2016:F56.8MM X 57.3MM. OBVIOUS ENDOLEAK COULD NOT BE CONFIRMED WITH CT DESPITE THE ANEURYSM GROWTH. HOWEVER, ADDITIONAL STENT GRAFT PLACEMENT WITH ZENITH EXTENSION DEVICE (ESBE-28-39) WAS PLANNED TO ASSIST PREVENTION OF FURTHER ENLARGEMENT OF THE ANEURYSM. ON (B)(6) 2016, SINCE THE DELIVERY SYSTEM OF THE EXTENSION WOULD NOT ADVANCE THROUGH THE ACCESS ROUTE AND ALSO BECAUSE THERE WAS NO TYPE IA ENDOLEAK OBSERVED, THE ADDITIONAL SG PLACEMENT WAS ABANDONED. ANGIOGRAPHY EXAMINED AFTER THE EVENT CONFIRMED RETROGRADE BLOOD FLOW INTO THE ANEURYSM FROM THE INFERIOR MESENTERIC ARTERY (IMA) AND COLLATERAL VESSELS, SO THE PHYSICIAN JUDGED THAT THE ANEURY

  Patient problems: Aneurysm; No Code Available

  MAUDE report 5773040 ↗
• InjuryMay 20, 2016Leak/Splash; Leak/Splash

  FLUID WAS LEAKING OUT OF THE CAPTOR VALVE WHEN THE 24 MM X 82 MM MAIN BODY GRAFT WAS INITIALLY FLUSHED AND REQUIRED ADDITIONAL FLUID TO FLUSH THE DEVICE. MIDWAY THROUGH THE PROCEDURE THE DOCTOR COMMENTED THAT THE VALVE WAS LEAKING STEADILY. HE PROCEEDED TO WRAP PACKS AROUND THE VALVE. WHEN THE GREY DILATOR WAS REMOVED THE BLOOD LOSS FROM THE VALVE INCREASED. AFTER USING THE CODA BALLOON THE GREY DILATOR WAS REINSERTED INTO THE VALVE TO REDUCE THE BLOOD LOSS. POST PROCEDURE THE DOCTOR ESTIMATED A BLOOD LOSS OF 1-1.5 LITRES AND X 2 UNITS OF PACKED CELLS WAS ORDERED.

  Patient problems: Blood Loss

  MAUDE report 5669365 ↗
• InjuryApr 13, 2016Leak/Splash; Leak/Splash

  AN EVAR PROCEDURE WAS BEING PERFORMED ON THE (B)(6) YEAR OLD COLON CANCER PATIENT. UPON FINAL RUN, A FABRIC TEAR WAS NOTED AND BELIEVED TO BE BETWEEN THE SECOND AND THIRD STENT ON THE RIGHT SIDE; TYPE III ENDO LEAK. NO FURTHER PROCEDURES WERE PERFORMED DUE TO THIS OCCURRENCE. PATIENT IS IN STABLE CONDITION AND WILL BE RETURNING IN THE FUTURE TO HAVE THE STATUS OF THE LEAK OBSERVED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 5574187 ↗