Cook recalls Zenith Alpha Abdominal Endovascular Grafts with catalog prefix ZIMB due to potential damaged bushing that could prevent proper deployment. Affected units may need replacement.
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.
Cook is recalling certain Zenith Alpha Abdominal Endovascular Grafts (catalog prefix ZIMB) because some units may have a damaged bushing that could prevent the graft from deploying correctly. This could lead to treatment failure for patients needing endovascular repair of abdominal aortic or aorto-iliac aneurysms.
The recalled grafts may contain a damaged bushing in the delivery system. This could prevent the graft from being fully deployed using the standard method described in the product instructions. If the graft doesn't deploy properly, the treatment may fail, requiring additional procedures.
Patients who have been prescribed this specific graft for abdominal aortic or aorto-iliac aneurysms are most at risk. Medical professionals using the product for endovascular repair may also be affected.
Check for the catalog prefix ZIMB on the product label. This recall applies to specific units sold for endovascular treatment of abdominal aortic or aorto-iliac aneurysms.
Reach out to Cook Inc. to confirm if your specific graft is affected and get instructions for replacement.
The recall indicates that some units may have a damaged bushing that could prevent proper deployment. Affected units should not be used until replaced.
Look for the catalog prefix ZIMB on the product label. This recall applies to specific units sold for endovascular treatment of abdominal aortic or aorto-iliac aneurysms.
No, but affected units should not be used until replaced. The recall does not require immediate discontinuation but replacement is needed for affected units.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-2546-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-2546-2020 from Cook. 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.
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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.
