Teleflex (NYSE:TFX) announced that it initiated a worldwide recall of its Arrow-Trerotola over-the-wire PTD (percutaneous thrombolytic device) kit.
Wayne, Pennsylvania-based Teleflex designed the Arrow-Trerotola (PTD) catheter in conjunction with the Arrow rotator drive unit to allow for the mechanical declotting of the native arterio-venous (AV) fistulae and synthetic dialysis graft.
The company initiated the recall through a voluntary field safety corrective action on Sept. 20, 2021, after receiving reports indicating that the PTD’s inner lumen (orange) detached from the device basket, according to a news release. If the orange inner lumen detaches from the basket, consequences depend upon whether and where the fractured dip component embolizes.
In most cases, Teleflex said, the embolization is local to the treatment target site and allows retrieval with an additional intervention (and the consequent delay of therapy). However, in some cases, embolization could be peripheral and result in or threaten to cause local ischemia. That could require a more complex, catheter-based intervention for retrieval or (rarely) surgical retrieval.
Devices affected and subject to the recall were manufactured between October 2019 and July 2021. Seven customer reports have been received, and one complaint said that a clinician used a snare to retrieve the detached lumen from the patient. There are no reports of long-term patient complications.
FDA classified this recall as Class I, the most serious kind, on Nov. 18, 2021. Teleflex said consumers who have affected products should immediately identify all patients that are currently exposed to use of this product, discontinue use and return all affected products to Teleflex.