Cook recalls Zenith Alpha Abdominal Endovascular Grafts with specific part numbers due to potential damaged gray safety lock knob that may cause deployment issues during surgery. Affected units may require medical intervention.
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.
Cook is recalling certain Zenith Alpha Abdominal Endovascular Grafts because they may have a damaged gray safety lock knob that could prevent proper deployment during surgery. This might lead to a prolonged procedure or open surgery.
The gray safety lock knob may be damaged, causing the graft to not deploy properly through standard or troubleshooting methods. This could lead to a prolonged procedure or open surgery being needed.
Medical professionals who use these grafts during procedures are most at risk. Patients using the recalled product could face extended surgery or open surgical intervention if the graft fails to deploy correctly.
Check for part numbers listed in the recall: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, and many others (see full list in the recall notice).
Identify the part number on the device to see if it matches the recalled list.
Reach out to Cook directly for specific instructions on whether the device needs repair or replacement.
The recall is due to a potential damaged gray safety lock knob that could prevent proper deployment of the graft during surgery.
Check the part number against the list provided in the recall notice. Contact Cook for specific guidance on next steps.
The recall states that affected products may lead to a prolonged procedure or open surgical intervention, which could be serious.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1844-2019 — Cook Cook Hello, I own a Cook that is covered by recall Z-1844-2019 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.
