Arrow-International, LLC (a subsidiary of Teleflex Inc.) is recalling the Arrow-Trerotola Percutaneous Thrombolytic Device due to risk of tip damage during use, which may result in tip detachment from the basket.
This could potentially lead to vascular injuries, including obstruction (blockage) of the vessel, additional thrombosis (blood clot), ischemia (inadequate blood supply), infarction (heart attack), infection or death.
As of December 2021, a total of 35 complaints reporting tip separation have been received. Of these 35 complaints, 14 reported injuries, and nine complaints involved use of a stent (support structure) to manage the separated tip. No deaths have been reported at this time.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Product Names: Arrow-Trerotola Percutaneous Thrombolytic Device (PTD)
Manufacturing Dates: January 1, 2020 to December 31, 2021
Distribution Dates: February 1, 2020 to December 31, 2021
Devices Recalled in the U.S.: 24,895
Date Initiated by Firm: December 22, 2021
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) consists of a catheter with an expandable basket attached to a drive cable. The catheter is used in with a low-speed, battery-operated rotator unit to remove blood clots in native arterio-venous fistulae and synthetic dialysis grafts.
