Cook Medical Zenith Alpha Abdominal Endovascular Graft (ICN 1112)

MHRA 2020/008/010/487/007
NHSSC: 38

Alert:

• Cook Medical has identified that specific lots of the Zenith Alpha Abdominal Endovascular Graft (ZIMB main body) may contain excess glue within the handle of the delivery system.
• This may result in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided in the IFU.
• Potential adverse events that may occur if an affected product is used include a prolonged procedure and/or open surgical repair.

Products Affected:

• There are 76 affected products available via NHS Supply Chain’s eDirect route.
• See our Downloads ▼ section to refer to the Field Safety Notice and product listing for further information on the affected product codes.
• Please note only the lot numbers listed in the Field Safety Notice are affected.
• Devices already implanted are not affect by this recall.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products.
• Quarantine any affected product/ lots.
• Customers are to complete the Customer Reply Form and email it to European.FieldAction@CookMedical.com.
• If you have any of the affected products please contact your NHS Customer Service Advisor with full details to enable us to monitor a return direct to the supplier and manage your credit.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.