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Zenith Flex G48450Recalls & reported problems

Cook Incorporated · Zenith Flex, AAA Endovascular Graft Iliac Leg · Class 3 · Implant

All models of Zenith Flex (54)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002484501), received between Nov 27, 2019 and Nov 27, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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

Device problems

  • Migration1

Patient problems

  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 27, 2019Migration; Migration

    IN ADDITIONAL INFORMATION RECEIVED ON 06AUG2020 AND 29AUG2020, IT WAS REPORTED THAT THE SURGEON WAS ABLE TO RELINE THE FLEX BIFURCATED GRAFT AND EXTEND THROUGH TO THE DISTAL LIMB WITH A ZISL-13-77. THIS PROCEDURE OCCUR END ON (B)(6) 2019. THE MIGRATION OF THE LIMB WAS NOTED ON A CT SCAN ON OR AROUND ON (B)(6) 2019. THERE WAS NO OCCLUSION OF THE LIMB AS OF ON (B)(6) 2019. THERE WAS NO AORTIC OR ILIAC ELONGATION NOTED. THE PATIENT WAS COMPLIANT WITH FOLLOW UP VISITS ON (B)(6) 2011, ON (B)(6) 2012, ON (B)(6) 2013, ON (B)(6) 2014 AND ON (B)(6) 2016.

    Patient problems: No Code Available

    MAUDE report 9387294 ↗

Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices

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Sources and updates

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