On October 5, 2016 Medtronic sent an Urgent Medical Device Recall Notice to all affected customers for specified lots of certain devices used to treat cerebral aneurysms, including the Pipeline Embolization Device, Alligator Retrieval Device, Marathon Flow Directed Micro Catheter, and X-Celerator Hydrophilic Exchange Guidewire manufactured over a time span from July 2014 to September 2016. This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient. PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event. The notice asked customers to:
- Remove and quarantine all unused affected products.
- Return the affected products to Medtronic. Customers are instructed to work with their Medtronic representative to assist in the return of the product, and assist with identifying a replacement product.
- Complete and return the Customer Confirmation Certificate via fax at 1-949-434-5020 to the attention of Neurovascular Quality.
For information, see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm531056.htm. Additional information about the voluntary recall, including the specific lot numbers of affected product, can be found at http://bit.ly/2dTvety. If you believe that you have been affected and wish to discuss this matter further, please contact our law firm.