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) fistu
Check against the official notice below — it lists the full affected range.
Teleflex Medical Inc. is recalling 3,668 units of the Arrow-Trerotola Percutaneous Thrombolytic Device (PTD), model PT-45509, due to reports that the device tip can separate during use. The affected devices were distributed worldwide, including throughout the United States and in Australia, Belgium, Canada, Chile, Czech Republic, Germany, Spain, France, Great Britain, Israel, Italy, South Korea, Kuwait, the Netherlands, Panama, the Philippines, Portugal, Saudi Arabia, and Turkey. The recall affects multiple lot numbers of both component types (PT-45509-S6 and PT-45509-T).
The record does not specify what actions affected consumers or healthcare facilities should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
The firm received reports indicating PTD tip separation during use.
Reason for recall: The firm received reports indicating PTD tip separation during use. Distribution: 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. Quantity: 3668 units Lot/code info: Lot Number / UDI: 13F20A0209 / (01)10801902121261(17)211231(10)13F20A0209, Components: Code PT-45509-S6, Lot number 14C19F1336; Code PT-45509-S6, Lot number 14C19J0340; Code PT-45509-T, Lot number 13C19L1173; Code PT-45509-T, Lot number 13C19M0193; Lot Number / UDI: 13F20B0054 / (01)10801902121261(17)220131(10)13F20B0054, Components: Code PT-45509-S6, Lot number 14C19F1336; Code PT-45509-S6, Lot number 14C19J0340; Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-T, Lot number 13C19L1173; Code PT-45509-T, Lot number 13C20A1583; Code PT-45509-T, Lot number 13C19M0193; Lot Number / UDI: 13F20B0527 / (01)10801902121261(17)220228(10)13F20B0527, Components: Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-S6, Lot number 14C20A0602; Lot Number / UDI: 13F20C0427 / (01)10801902121261(17)220228(10)13F20C0427, Components: Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-T, Lot number 13C20A2409; Code PT-45509-T, Lot number 13C20C0842; Lot Number / UDI: 13F20D0127 / (01)10801902121261(17)220331(10)13F20D0127, Components: Code PT-45509-S6, Lot number 14C20A0602; Code PT-45509-S6, Lot number 14C20C1054; Code PT-45509-T, Lot number 13C20D0847; Lot Number / UDI: 13F20D0402 / (01)10801902121261(17)220430(10)13F20D0402, Components: Code PT-45509-S6, Lot number 14C20C1054; Code PT-45509-S6, Lot number 14C20D0569; Code PT-45509-T, Lot number 13C20D2088; Lot Number / UDI: 13F20F0390 / (01)10801902121261(17)220531(10)13F20F0390, Components:
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.