TELEFLEX MEDICAL INC recalls Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T

Recalled February 23, 2022 · FDA recall Z-0627-2022 · TELEFLEX MEDICAL

Hazard

The firm received reports indicating PTD tip separation during use. · FDA Class I

Units

3668 units

Sold at

Worldwide distribution: US Nationwide and the countries of AU, BE, CA, CL, CZ, DE, ES, FR, GB, IL, IT, KR, KW, NL, PA, PH, PT, SA, TR.

Description

The firm received reports indicating PTD tip separation during use.

Product

Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

Manufacturer(s)

TELEFLEX MEDICAL INC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →