Zenith Flex G48427Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10827002484273), received between Aug 21, 2014 and Mar 29, 2023 — classified as 2 deaths, 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathMar 29, 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; Pain; Rupture

  MAUDE report 16636745 ↗
• InjuryFeb 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS PROVIDED ON 22FEB2023. CALCIFICATION WAS PRESENT THROUGHOUT THE AORTIC BIFURCATION AND INTO THE COMMON ILIAC ARTERIES. THE ENDOLEAK IS BELIEVED TO BE A HOLE OR A TEAR IN THE GRAFT MATERIAL AS THE ANGIOGRAM SHOWS A JET OF CONTRAST AT ONE POINT. THE ENDOLEAK IS NOT BELIEVED TO INVOLVE THE BIFURCATION OF THE MAIN BODY GRAFT (TFFB-32-82-ZT). THE ENDOLEAK WAS LOCATED CLOSE TO THE TOP OF THE PROXIMAL EDGE ON THE IPSILATERAL (RIGHT LIMB). HOWEVER, DUE TO THE DIFFICULTY IN IMAGING THE ENDOLEAK, THE SURGEON WISHES TO RELINE THE INDWELLING GRAFTS WITH A CUSTOM MADE AAA-BIFURCATED-INVERTED LIMB GRAFT.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 16418433 ↗
• MalfunctionJan 17, 2020Difficult 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 Code Available; No Consequences Or Impact To Patient

  MAUDE report 9602525 ↗
• DeathFeb 26, 2019Obstruction of Flow; Obstruction of Flow

  THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: Death; No Code Available; Thrombosis

  MAUDE report 8371736 ↗
• MalfunctionApr 5, 2018Occlusion Within Device; Occlusion Within Device

  THIS REPORT IS RELATED TO INFORMATION FOUND AS A PART OF THE INVESTIGATION OF PREVIOUSLY REPORTED MANUFACTURER REPORT # 1820334-2017-04263. THE INVESTIGATION IDENTIFIED DURING IMAGING REVIEW COMPLETED ON (B)(6) 2018, MILD SMOOTH MURAL THROMBUS OF THE ZENITH AAA MAIN BODY: TFFB-32-82-ZT ((B)(4)). THERE HAS BEEN NO PREVIOUS INDICATION OF THROMBUS FORMATION IN THE TFFB-32-82-ZT REPORTED BY THE USER FACILITY.

  Patient problems: Thrombus

  MAUDE report 7401653 ↗
• MalfunctionMay 16, 2016Leak/Splash; Leak/Splash

  DURING AN EVAR PROCEDURE ON A (B)(6) YEAR OLD MALE PATIENT, WHEN THE GRAY PUSHER WAS REMOVED FROM DELIVERY SYSTEM ON THE MAIN BODY SIDE (PATIENT'S LEFT), THE USER ATTEMPTED TO CLOSE THE HEMOSTATIC VALVE BUT WAS STILL LEAKING IN THE CLOSED POSITION. THE DEVICE WAS LEAKING HEP SALINE DURING PREPARATION/FLUSHING. THE SHEATH WAS EXCHANGED TO LIMIT THE BLOOD LOSS. 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 NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5657033 ↗
• InjuryMar 20, 2015Migration or Expulsion of Device; Activation, Positioning or Separation Problem

  A (B)(6) MALE PT UNDERWENT A 111 REPAIR. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR, ALTHOUGH THE AORTA BIFURCATION WAS A BIT THIN. AFTER PLACEMENT OF THE COOK MAIN BODY GRAFT FROM THE RIGHT, THE PHYSICIAN CANNULATED THE LEFT SIDE AND INSERTED THE DELIVERY SYSTEM OF A COOK ILIAC LEG GRAFT FROM THE LEFT AND PLACED THE SENT GRAFT. THEN DEPLOYED THE RIGHT LIMB OF THE MAIN BODY AND REMOVED THE GRAY POSITIONER WITH DIFFICULTY. ADDITION TO THE DIFFICULTY, HE ALSO FELT SOMETHING UNUSUAL DURING REMOVING THE GRAY POSITIONER, SO HE PERFORMED BALLOONING AND DSA (DIGITAL SUBSTRACTION ANGIOGRAPHY) FOR RAO (RIGHT ANTERIOR OBLIQUE), LAO (LEFT ANTERIOR OBLIQUE) AND THE AP (ANTERIOR POSTERIOR), AND DETERMINED THE ILIAC LEG GRAFT COULD NOT BE PLACED INSIDE THE MAIN BODY. THE PHYSICIAN DECIDED TO CONVERT TO AORTO-UNI-ILIAC, BUT THE MAIN BODY MIGRATED PROXIMALLY WHEN HE INSERTED THE DELIVERY SYS OF A COOK ZENITH ENDOVASCULAR CONVERTER AND THE MAIN BODY COVERED THE RENAL ARTERIES AND THE SMA (SUPERIOR MESENTERIC ARTERY). TO AVOID ISCHEMIA OF THE ORGANS, HE IMMEDIATELY CONVERTED THE PROCEDURE TO OPEN SURGERY TO REMOVE THE MAIN BODY AND THE ILIAC LEG GRAFT, AND REPLACED THE AORTA WITH

  Patient problems: Migration; Occlusion; Surgical procedure, additional

  MAUDE report 4629625 ↗
• InjuryDec 5, 2014Leak/Splash

  DURING AN EVAR PROCEDURE ON A (B)(6) MALE PATIENT ON (B)(6) 2014, THE ZENITH FLEX MAIN BODY WAS INSERTED. THE PHYSICIAN COMMENTED THAT THE CAPTOR VALVE ON THE MAINBODY DELIVERY SYSTEM WAS LEAKING THROUGHOUT THE DURATION OF THE CASE. GRAFTS WERE IMPLANTED BUT THE DELIVERY SYSTEMS WERE REMOVED NORMALLY AS WITH ANY EVAR. THE PHYSICIAN TOLD THE SCRUB TECHS TO SAVE THE DELIVERY SYSTEM SO THAT THE REP COULD RETURN IT AND REPORT THE PROBLEM. THE PHYSICIAN REPORTED THAT THE ESTIMATED BLOOD LOSS FROM THE LEAKING VALVE WAS APPROX 300ML. ONE UNIT OF BLOOD TRANSFUSED POST-OP TO COUNTER BLOOD LOSS. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: Transfusion of blood products

  MAUDE report 4335997 ↗
• InjuryAug 21, 2014Occlusion Within Device

  A (B)(6) MALE PT IN (B)(4) UNDERWENT A SECONDARY INTERVENTION ON (B)(6) 2013 (DAY OF PROCEDURE) DUE TO THROMBOSIS IN THE LEFT ILIAC LEG EXTENSION. THE PT WAS BEING TREATED FOR AN AORTOILIAC ANEURYSM. THE MAXIMUM AORTIC ANEURYSM DIAMETER WAS 3.5 CM. THE PROXIMAL NECK HAD AN INVERTED FUNNEL SHAPE WITH NO PLAQUE/THROMBUS. THE LEFT ILIAC ARTERY HAD MODERATE TORTUOSITY, CALCIFICATION, AND OCCLUSIVE DISEASE. THE RIGHT ILIAC ARTERY HAD MILD TORTUOSITY, CALCIFICATION, AND OCCLUSIVE DISEASE. THE PT RECEIVED A MAIN BODY DEVICE, RIGHT AND LEFT SPIRAL-Z ILIAC LEGS, AND LEFT AND RIGHT ZENITH BRANCH. BIFURCATED ILIAC SIDEBRANCH LEG EXTENSIONS. AN UNCOVERED ILIAC STENT WAS ALSO PLACED ON THE LEFT SIDE AFTER THE PROCEDURE DUE TO KINK. DIFFICULTY WITH ADVANCING THE DELIVERY SYSTEM WAS NOTED WITH THE LEFT ILIAC LEG AND THE LEG ILIAC LEG EXTENSION. NO DEPLOYMENT DIFFICULTIES WERE NOTED WITH THE OTHER DEVICES. NO OTHER DEVICES WERE PLACED ON NO OTHER PROCEDURES WERE PERFORMED. A MOLDING BALLOON WAS USED BUT NO DETAILS WERE PROVIDED REGARDING ITS USE. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICE WAS PATENT WITH NO EXTERNAL COMPRESSION, ENDOLEAKS, OR THROMBUS. A FLOW LIMITING KINK WAS NOTED IN THE LEF

  Patient problems: Thrombus

  MAUDE report 4036741 ↗