Teleflex Recalls Its Percutaneous Thrombolytic Device Due to Lumen Detaching

The FDA has deemed Teleflex’s worldwide recall of its Arrow-Trerotola over-the-wire percutaneous thrombolytic device kit to be a class I recall because there is “a reasonable probability that the use of or exposure to [the] product will cause serious adverse health consequences or death.”

The recall followed reports indicating that the inner lumen may detach from the device’s basket, the Wayne, Pa.-based company said. Four products that were manufactured from October 2019 through July, a total of 53 lots, are covered in the recall.

The company has received seven customer complaints about the problem so far, but said no long-term patient complications have been reported.