Medical device manufacturer, Cook Medical, has issued a medical device safety alert concerning its Zenith Alpha Abdominal Endovascular Graft. The locally affected product in Hong Kong is as follows:
The manufacturer has identified that the affected product 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 Instructions For Use (IFU).
According to the manufacturer, the troubleshooting deployment method within the IFU has been able to be used successfully. Potential adverse events that may occur if an affected product is used include a prolonged procedure and minimally invasive endovascular intervention. Products already implanted are not affected by the recall.
Users are advised to examine inventory immediately to determine if they have the affected products, quarantine any affected products that remains unused, immediately cease all distribution and use of the affected products.
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 product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 June 2020