Medical device manufacturer, Cook Medical, has issued a medical device safety alert concerning its Zenith Alpha Abdominal Endovascular Graft. The details of the affected products are as follow:
The manufacturer has identified that specific lots of the Zenith Alpha Abdominal Endovascular Graft 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.
The manufacturer has received two complaints for this issue. The procedures were able to be completed successfully without any serious adverse effects to the patients. Potential adverse events that may occur if an affected product is used include a prolonged procedure and/or open surgical repair. Devices already implanted are not affected by this recall.
Affected users should examine inventory immediately to determine if they have affected products and quarantine any affected products that remains unused. Affected users should immediately cease all distribution and use of this product. Product recall is on-going.
The manufacturer is removing products potentially impacted from the market. Additionally, an investigation has been opened to determine the appropriate corrective actions to prevent reoccurrence of a similar issue.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 12 August 2020