FDA-Device2022-02-23Class I
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.
TELEFLEX MEDICAL INC
Hazard
The firm received reports indicating PTD tip separation during use.
Sold states
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.
Affected count
3668 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0627-2022Don't want to check this manually?
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