Cook Inc. recalls Zenith Alpha Abdominal Endovascular Grafts with excess glue in the handle that may prevent proper deployment. Affected units have specific reference part numbers and lot numbers listed in the recall notice.
May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the IFU
Cook Inc. is recalling certain Zenith Alpha Abdominal Endovascular Grafts due to excess glue in the handle that may prevent proper deployment of the graft. This could lead to treatment failure or complications during endovascular procedures.
The grafts may contain excess glue in the handle that prevents the graft from deploying correctly using standard methods or troubleshooting procedures. This could lead to treatment failure or complications during the procedure.
Patients who have received the recalled Zenith Alpha Abdominal Endovascular Grafts for abdominal aortic or aorto-iliac aneurysms are affected. Medical professionals using these grafts for endovascular treatment may also be at risk.
Check the reference part numbers (RPN) listed: ZIMB-22-108 through ZIMB-36-98. Also check the lot numbers provided for each part number in the recall notice.
Reach out to Cook Inc. to confirm if your specific model and lot number is affected and to get instructions for replacement or repair.
The grafts may contain excess glue in the handle that prevents proper deployment using standard methods or troubleshooting procedures.
Check the reference part numbers (RPN) listed: ZIMB-22-108 through ZIMB-36-98. Also check the lot numbers provided for each part number in the recall notice.
No, but you should contact Cook Inc. to confirm if your specific model and lot number is affected and to get instructions for replacement or repair.
We’ve drafted a message you can send Cook Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-2964-2020 — Cook Inc. Cook Inc. Hello, I own a Cook Inc. that is covered by recall Z-2964-2020 from Cook Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
