FDA Device recall Z-2546-2020

Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients wit…

FDA Device
Class II
terminated
Published 2020-07-15

On 2020-07-15 the FDA classified a Class II recall of Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients wit… by Cook, citing identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standa….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2546-2020
Classification	Class II
Status	terminated
Initiated	2020-06-02
Published	2020-07-15
Last updated	2026-09-13 11:55 UTC
Company	Cook
Distribution	n/a

Product

Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.

Reason

Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the IFU.

Identifiers

code_info	10225099 13086631 10236496 10236495 13086628 13086629 13086630 10199454 10199470 10248188 10248189 10205533… 10225099 13086631 10236496 10236495 13086628 13086629 13086630 10199454 10199470 10248188 10248189 10205533 10205533X 10261154 10262338 10262339 10262340 10208616 10208617 10222621 10216004 10225098 10236497 10241031 10242503 10242504 10248190 13086633 10208619 10208618 10215770 10222622 10236499 10236498 10242505 10258804 10265109 13059620 13090275 10238909 10245880 10248214 10250362 13098164 10250364 10250361 10262345 10262346 10269483 10250363 10222636 13059866 10233563 10291651 10236429 10238910 10238912 10238913 10238914 10238916 10241034 10241034X 13094887 10238911 10238915 10241502 10238903 10245881 10247236 10247237 10247238 10247235 13086610 10249320 10249321 10250370 10250371 10199450 10199477 10199463 10199467 10199478 10204345 10205528 10238917 10250366 13098165 10205525 10205527 10250365 10250367 10251227 10250372 10250373 10250374 10205526 10250368 10250369 10269485 10199475

code_info

10225099 13086631 10236496 10236495 13086628 13086629 13086630 10199454 10199470 10248188 10248189 10205533…

10225099 13086631 10236496 10236495 13086628 13086629 13086630 10199454 10199470 10248188 10248189 10205533 10205533X 10261154 10262338 10262339 10262340 10208616 10208617 10222621 10216004 10225098 10236497 10241031 10242503 10242504 10248190 13086633 10208619 10208618 10215770 10222622 10236499 10236498 10242505 10258804 10265109 13059620 13090275 10238909 10245880 10248214 10250362 13098164 10250364 10250361 10262345 10262346 10269483 10250363 10222636 13059866 10233563 10291651 10236429 10238910 10238912 10238913 10238914 10238916 10241034 10241034X 13094887 10238911 10238915 10241502 10238903 10245881 10247236 10247237 10247238 10247235 13086610 10249320 10249321 10250370 10250371 10199450 10199477 10199463 10199467 10199478 10204345 10205528 10238917 10250366 13098165 10205525 10205527 10250365 10250367 10251227 10250372 10250373 10250374 10205526 10250368 10250369 10269485 10199475

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2546-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.