Medtronic Recall Issued for Neurovascular Products Due Defective Coatings, Blood Clot Risk
A recall has been issued fo four different Medtronic neurovascular products, including embolization devices, guidewires and micro catheters, which each have a coating that may flake off and enter the blood stream, potentially increasing the risk of blood clots and other injuries.
Medtronic announced a Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, Ultraflow and Marathon Flow Directed Micro Catheter recall on October 14, impacting devices that have a polytetrafluoroethylene (PTFE) coating, which may separate from the delivery wire or stylets and enter the blood stream.
According to the press release, if the coating enters the blood stream, it could result in a thromboembolic event. However, Medtronic said it is unaware of any reports of patient injuries linked to the problem.
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The Medtronic recall includes 1,742 lots of the first generation of Pipeline embolization devices, which are used to treat large or giant wide-necked intracranial aneurysms in adults. The device’s guidewire uses the PTFE coating. However, second generation Pipeline devices are not affected.
The action also includes 171 lots of the Alligator retrieval device, which is used for peripheral and neuro-vasculature foreign body removal; 210 lots of the X-Celerator hydrophillic guidewires, which are used to place catheters in the vasculature; and 1,790 lots of the Ultraflow and Marathon Flow Directed Micro Catheters, which are used to inject therapeutic agents and diagnostic agents into the blood.
A total of 84,378 recalled Medtronic units were distributed worldwide, manufactured from July 2014 to September 2016. Medtronic has published a list of all affected lots (PDF).
The company says it sent out a recall letter to its customers on October 5, and requested that all of the affected products be returned to Medtronic. Customers with questions can contact the Medtronic Lifeline Service at 1-877-526-7890.
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