FDA Provides Update on Arrow International’s Recall of Thrombolytic Device

The FDA has issued on update on Arrow International’s Dec. 22 recall of its Arrow-Trerotola percutaneous thrombolytic device, deeming it a Class 1 recall because of the risk of serious injury or death.

The device consists of a catheter with an expandable basket attached to a drive cable. The catheter is used with a battery-operated rotator unit to remove blood clots in arterio-venous fistulas.

The reason for the recall is the risk of tip damage during use, which may result in tip detachment and potentially lead to vascular injuries, including blockage of the vessel, additional blood clots, inadequate blood supply, heart attack, infection or death.

The 24,895 affected products were manufactured between Jan. 1, 2020, and Dec. 31, 2021, and were distributed from Feb. 1, 2020, to Dec. 31, 2021. As of December, there were 35 complaints reporting tip separation, including 14 reported injuries. No deaths have been reported, the agency said.