TELEFLEX MEDICAL INC recalls 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-030

Recalled February 23, 2022 · FDA recall Z-0628-2022 · TELEFLEX MEDICAL

Hazard

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

Units

5530 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

5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) 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 →