Class 2 Device Recall Zenith Alpha Abdominal Endovascular Graft

• Date Initiated by Firm: April 26, 2019
• Date Posted: June 19, 2019
• Recall Status: Terminated on November 08, 2019
• Recall Number: Z-1844-2019
• Recall Event ID: 82904
• Product Classification: System, endovascular graft, aortic aneurysm treatment - Product Code MIH
• 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
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• Recalling Firm/ Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Department; 812-339-2235
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Under Investigation by firm
• Action: Urgent Medical Device Recall notification letters dated 4/26/19 were sent to customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns, contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.
• Quantity in Commerce: 1027
• Distribution: No US distribution. Product distributed to the following foreign countries: Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile Columbia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Morocco, Netherlands, Norway, Poland, Portugal, Reunion, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.