FDA Device recall Z-1844-2019
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-9…
- FDA Device
- Class II
- terminated
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-9… by Cook, citing may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method prov….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1844-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-26 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Cook |
| Distribution | n/a |
Product
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98
Reason
may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.
Identifiers
| code_info | 9221784, 9228731, 9232249, 9246529, 9272685, 9272835, 9276029, 9276400, 9303245, 9373623, 9406776, 9466908, 9506559, 9…9221784, 9228731, 9232249, 9246529, 9272685, 9272835, 9276029, 9276400, 9303245, 9373623, 9406776, 9466908, 9506559, 9525188, 9557569, 9566160, 9566211, 9575380, 9620378, 9620379, 9620382, 9625916, 9625917, 9636371, 9640584, 9663986 9406777, 9522416, 9566161, 9575382, 9625918, 9656992 9557570, 9566162, 9575383, 9625919, 9625920, 9656978 9221629, 9232247, 9276401, 9303246, 9373624, 9394051, 9403262, 9406778, 9406779, 9406780, 9453299, 9466909, 9466910, 9482147, 9486290, 9486313, 9506616, 9522418, 9522419, 9525189, 9529047, 9534284, 9555442, 9555453, 9555475, 9566214, 9572229, 9575386, 9592482, 9592485, 9594196, 9594205, 9609105, 9617443, 9617445, 9625921, 9625922, 9625923, 9636298, 9636330, 9640585, 9642977, 9650113, 9650114, 9394051X, NS9584273, NS9584274, NS9584275, NS9584276, NS9584277, NS9584278, NS9584279, NS9584280, NS9584281, NS9584282 9214951, 9221781, 9221785, 9221786, 9221787, 9228739, 9232238, 9232239, 9232250, 9234942, 9239302, 9239303, 9246530, 9272665, 92726 |
|---|
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-1844-2019%22
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