Zenith Flex G32184Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002321844), received between Jul 7, 2017 and Oct 5, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT UNDERWENT ENDOVASCULAR ANEURYSM REPAIR (EVAR) AGAINST ABDOMINAL AORTIC ANEURYSM (AAA) AND ANEURYSM IN THE LEFT COMMON ILIAC ARTERY. THE PATIENT ANATOMY WAS SUITABLE FOR THE PROCEDURE. SEVERE CALCIFICATION WAS OBSERVED IN THE ACCESS ROUTE, BUT THE DELIVERY SYSTEM OF THE MAIN BODY PASSED THROUGH THE CALCIFIED AREA WITHOUT PROBLEMS. THE DEVICES BELOW WERE PLACED IN THE TARGET SITE FOLLOWING THE INSTRUCTIONS FOR USE. TFB-32-74-ZT, LOT#7987338 - RIGHT FEMORAL APPROACH, MAIN BODY, ZSLE-13-122-ZT, LOT#5691101 - LEFT FEMORAL APPROACH, CONTRALATERAL LEG, ZSLE-20-56-ZT, LOT#7791648 - RIGHT FEMORAL APPROACH, IPSILATERAL LEG. ANGIOGRAPHY CONFIRMED A PROXIMAL TYPE 1 ENDOLEAK. THE PHYSICIAN DETERMINED TO PLACE A PROXIMAL EXTENSION (ESBE-32-39 LOT#6800050) BY USING THE SAME ACCESS ROUTE, RIGHT FEMORAL APPROACH, USED FOR PLACEMENT OF THE MAIN BODY AND IPSILATERAL LEG. HOWEVER, THE DELIVERY SYSTEM GOT STUCK IN THE CALCIFICATION NEAR THE BIFURCATION OF INTERNAL AND EXTERNAL ILIAC ARTERY. AS THE DELIVERY SYSTEM COULD NOT BE ADVANCED FURTHER, PLACEMENT OF THE EXTENSION WAS GIVEN UP AND TOUCH-UP BALLOONING WAS CONDUCTED. THE AMOUNT OF THE ENDOLEAK FLOW DECREASED BY THE BALLOONING, YET IT

  Patient problems: Vascular Dissection

  MAUDE report 6915527 ↗
• MalfunctionJul 7, 2017Defective Device; Defective Device

  IT WAS REPORTED THAT A PROBLEM WAS NOTICED WITH A ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION. PRIOR TO PATIENT CONTACT FOR A PLANNED ENDOVASCULAR ANEURYSM REPAIR PROCEDURE (EVAR) THE SURGEON NOTICED THAT THERE WAS A BARB STICKING THROUGH. CLARIFICATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. THE SHEATH WASN'T SMOOTH AND THEY DIDN'T WISH TO USE THIS ON A PATIENT, SO THEY USED THE SPARE DEVICE. THE PROBLEM WAS DISCOVERED PRIOR TO PATIENT CONTACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6693445 ↗