The FDA has announced that Teleflex Incorporated is recalling its Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR due to issues with its inner lumen detaching while in use.
The solution—which includes a catheter, hand-held disposable rotator drive unit and introducer sheath—is used to help clinicians with the mechanical declotting of native arterio-venous fistulae and synthetic dialysis grafts.
“If the orange inner lumen detaches from the basket, health consequences depend upon whether, and where, the fractured tip component embolizes,” according to the company announcement on the FDA’s website. “In most cases, the embolization is local to the treatment target site, allowing retrieval with an additional intervention and consequent delay of therapy. In some cases, the embolization could be central or peripheral and result in, or threaten to cause, local ischemia. Such an occurrence could require a more complex catheter-based intervention for retrieval, or rarely, surgical retrieval.”
This is a Class I recall, meaning the use of this device “may cause serious injuries or death.” Teleflex has received a total of seven customer complaints so far. There are no reports of long-term patient complications.
All devices were manufactured from October 2019 to July 2021.
Read the full announcement here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.