FDA: Class I recall of Teleflex percutaneous thrombolytic device kit

Editor's Note

The Food and Drug Administration (FDA), on November 30, identified the worldwide recall by Teleflex of its Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR as Class I, the most serious.

The device, which is used for mechanical declotting of native arteriovenous fistulae and synthetic dialysis grafts, was recalled because the inner lumen may detach from the device’s basket.

As of November, seven customer complaints had been received. No long-term patient complications have been reported.

The recalled devices were manufactured from October 2019 through July 2021.