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TELEFLEX MEDICAL INC recalls Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65
Recalled February 23, 2022 · FDA recall Z-0624-2022 · TELEFLEX MEDICAL
Hazard
The firm received reports indicating PTD tip separation during use. · FDA Class I
Units
1400 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 Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS 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 →