Medtronic recalls thousands of stent grafts

[Image courtesy of Medtronic]

Some Endurant and Endurant II bifurcated stent graft systems, more than 3,000 of them globally, could fool doctors into thinking a more serious endoleak is taking place during the implant procedure, causing the doctors to take unnecessary extra interventions, Medtronic is warning in a letter to health providers published in Europe.

The voluntary recall announcement, posted today on the website of Germany’s Federal Institute for Drugs and Medical Devices ( BfArM ), tells health providers to identify and return the Endurant and Endurant II stents covered in the recall that are still in inventory. Since potential problems take place during implanting, the recall doesn’t cover stents already implanted inside people.

“Patients who have been implanted with an EndurantEndurant II 23mm or 25mm bifurcated stent graft system affected by this recall do not require any additional follow up due to this observation and should continue to be monitored in accordance with standard practice,” Medtronic spokesperson Krystin Hayward said when contacted by MDO.

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