Zenith Flex G48424Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002484242), received between Jul 1, 2015 and Jun 9, 2022 — classified as 1 death, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2022Difficult or Delayed Activation; Mechanical Jam; Difficult or Delayed Activation; Mechanical Jam

  IT WAS REPORTED THE TOP CAP OF ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY WAS DIFFICULT TO ADVANCE DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). AS A RESULT, THE GRAFT MIGRATED "SLIGHTLY" DISTALLY; HOWEVER, THE USER WAS SATISFIED WITH THE OUTCOME. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14648887 ↗
• MalfunctionSep 22, 2020Complete Blockage; Complete Blockage

  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 10570423 ↗
• MalfunctionNov 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9310104 ↗
• DeathDec 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN (B)(6) FEMALE PATIENT DIED AFTER UNDERGOING AN ENDOVASCULAR ANEURYSM REPAIR PROCEDURE (EVAR). THE CATALOG NUMBERS OF THE IMPLANTED DEVICES INCLUDE: TFFB-30-111-ZT, ZSLE-16-90-ZT (LEFT), ZSLE-16-56-ZT (RIGHT), ZSLE-11-90-ZT (RIGHT) BY RIGHT APPROACH. THERE WAS SEVERE CALCIFICATION IN THE ACCESS ROUTE. HOWEVER, THE DIAMETER OF THE ACCESS ROUTE ALLOWED DELIVERY SYSTEMS TO BE ADVANCED. THE PATIENT WAS NOT SUITABLE FOR THE PROCEDURE BECAUSE OF CIRCUMFERENTIAL CALCIFICATION IN THE COMMON ILIAC ARTERY (CIA). DURING THE PROCEDURE, A PROXIMAL TYPE I ENDOLEAK WAS SUSPECTED, SO AN ADDITIONAL DEVICE WAS PLACED (CATALOG NUMBER: ESBE-30-39) BY RIGHT APPROACH. THE ENDOLEAK WAS RESOLVED BY PLACING THE EXTENSION DEVICE AS PER TROUBLESHOOTING TECHNIQUES IN THE DEVICE LABELING. THE PROCEDURE WAS FINISHED AND THE PATIENT RECOVERED FROM ANESTHESIA. AT 1500, THE PATIENT WAS RETURNED TO INTENSIVE CARE UNIT (ICU). AT 1620, THE PATIENT SUDDENLY STOPPED RESPONDING TO CALLS. VENTRICULAR FIBRILLATION (VF) WAVEFORM WAS CONFIRMED ON THE ELECTROCARDIOGRAPH MONITOR. AFTER CONFIRMING THAT NO PULSE COULD BE FELT, CARDIOPULMONARY RESUSCITATION (CPR) BEGAN AND INCLUDED: CHEST COMPRESSION, INTU

  Patient problems: Death; Rupture

  MAUDE report 7143837 ↗
• InjuryMar 8, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENDOVASCULAR AORTIC ANEURYSM REPAIR WITH PLACEMENT OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. CUSTOMER INDICATED THAT THE INNER LUMEN OF THE SHEATH VALVE DISLODGED WHILE RETRACTING THE GREAT DILATOR. AN UNSPECIFIED AMOUNT OF BLOOD LEAKED FROM THE DEVICE. THE SHEATH WAS REMOVED AND EXCHANGED FOR ANOTHER 20FR SHEATH TO PREVENT FURTHER BLOOD LOSS. THERE WAS 'SOME' UNSPECIFIED ANATOMICAL TORTUOSITY REPORTED. NO OTHER PROCEDURAL ANOMALIES WERE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE ARE NO REPORTED ADVERSE PATIENT OUTCOMES RELATED TO THIS EVENT. NO FURTHER PATIENT OR PROCEDURE INFORMATION WAS PROVIDED. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 6387455 ↗
• InjuryJul 1, 2015Leak/Splash

  A MALE PATIENT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2015. THE PHYSICIAN PLACED THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY AND REMOVED THE GREY POSITIONER OUT OF THE MAIN BODY SHEATH. ONCE REMOVED, THE VALVE WAS CLOSED AND EXCESSIVE LEAKAGE OCCURRED. THE ILIAC WAS INSERTED INSIDE THE SHEATH AND AT THIS PORT, THE LEAK WAS COMING THROUGH THE HEMOSTATIC VALVE BETWEEN THE CLEAR CYLINDER AND THE TWIST OF THE VALVE. A TOWEL WAS USED TO TRY AND HELP CONTROL THE LEAK BUT THIS DID NOT WORK. THE SHEATH WAS REMOVED AND AFTER BALLOONING THE PATIENT WAS CLOSED OUT. THE PATIENT'S BLOOD PRESSURE DROPPED TO 68/40 WITH APPROXIMATELY 1500CC BLOOD LOSS FROM THE SHEATH. THE PATIENT WAS GIVEN 700 UNITS OF BLOOD AND THE PATIENTS' BLOOD PRESSURE RESUMED. 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: Blood Loss

  MAUDE report 4898382 ↗