FDA designates recall of percutaneous thrombolytic devices as class I
Teleflex announced a worldwide recall of its percutaneous thrombolytic device for mechanical declotting of native arteriovenous fistulae and synthetic dialysis grafts.
The recall affects the Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7R, in conjunction with the Arrow Rotator Drive Unit, due to risk for detachment of the orange inner lumen from the device basket, according to a company announcement.
Embolization due to orange inner lumen detachment from the basket is, in most cases, local to the treatment target site, allowing retrieval with an additional intervention and subsequent delay of therapy. However, the embolization could be central or peripheral and threaten local ischemia and may require a more complex intervention for retrieval, according to the announcement.
The FDA has designated the recall as class I, the most serious type of recall.
Devices manufacturer from October 2019 to July 2021 are subject to the recall.
As of November, seven customer complaints have been received for this issue. No long-term patient complications have been reported, according to the announcement.