FDA: Class I recall of Arrow International’s Arrow-Trerotola PTD

Editor's Note

The Food and Drug Administration (FDA) on February 23 identified the recall by Arrow International (Reading, Pennsylvania), a subsidiary of Teleflex Inc, of its Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) as Class I, the most serious.

The recall was initiated because of the risk of tip damage during use that may result in tip detachment from the expandable basket when removing blood clots, which can lead to vascular injuries and blockage, heart attack, or death.

As of December 2021, there have been 35 complaints of tip separation that have caused 14 injuries, and there have been 9 complaints linked to the use of a stent to manage the separated tip. No deaths have been reported.

Distribution dates were February 1, 2020 to December 31, 2021.