Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Endurant II/IIs Stent Graft System [Model: ESBF2514C103EE, ESBF2814C103EE, ESBF3214C103EE, ESBF3614C103EE, ETCF2525C49EE, ETCF2828C49EE, ETUF2514C102EE, ETUF2814C102EE; Serial Number: Multiple].
The manufacturer has identified that devices built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention that attempt to remove the taper tip. There is also a potential that the taper tip is intentionally left behind in the patient, if not easily removable. Serious injuries and/or deaths could occur also due to detachment of the taper tip from the delivery system during the implant procedure.
The manufacturer advises affected user to identify, quarantine and return all unused affected product. Affected users are also advises to notify the manufacturer of any adverse events or quality problems associated with the use of this product.
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 24 Dec 2021