Arrow Thrombolytic Device Recall Class 1

FDA says the 12/22/21 Arrow International recall of its Arrow-Trerotola percutaneous thrombolytic device is Class 1. An agency notice says the company recalled 24,895 units manufactured between 1/1/20 and 12/31/21 and distributed between 2/1/20 and 12/31/21.

The device consists of a catheter with an expandable basket attached to a drive cable. The catheter is said to be used with a low-speed, battery-operated rotator unit to remove blood clots in native arterio-venous fistulae and synthetic dialysis grafts.

Arrow recalled the devices due to a risk of tip damage during use, which could result in tip detachment from the basket. FDA says that as of 12/2021, 35 complaints reporting tip separation had been received, with 14 reporting injuries and nine involving the use of a stent to manage the separated tip. No deaths had been reported as of 12/2021.