Arrow International recalled over 24,000 percutaneous thrombolytic devices due to risk of tip damage during use, which could result in tip detachment from the basket.
The FDA classified the recall as a Class I, the most serious type, according to a Feb. 23 news release.
A total of 35 complaints have been received since December 2021. Of the 35 complaints, there have been 14 reported injuries, and nine complaints involved use of a stent to manage the separated tip. No deaths have been reported at this time, according to the FDA.