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.

Class I - Dangerous

🏥 Medical Devices Recalled: January 11, 2022 TELEFLEX MEDICAL Surgical Instruments Nationwide

What Should You Do?

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Lot Number / UDI: 13F20A0359 / (01)10801902121285(17)211231(10)13F20A0359, Components: Code PT-65509-S, Lot number 14C19H0644; Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19J0203; Code PT-01000-D, Lot number 13C19L2034; Lot Number / UDI: 13F20A0519 / (01)10801902121285(17)211131(10)13F20A0519, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19J0203; Code PT-03000, Lot number 13C19M0279; Code PT-01000-D, Lot number 13C20A0986; Lot Number / UDI: 13F20B0140 / (01)10801902121285(17)220131(10)13F20B0140, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19M0279; Code PT-03000, Lot number 13C19M0954; Code PT-01000-D, Lot number 13C20A2408; Lot Number / UDI: 13F20B0423 / (01)10801902121285(17)220228(10)13F20B0423, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19M0954; Code PT-03000, Lot number 13C20A0627; Code PT-01000-D, Lot number 13C20B1758; Lot Number / UDI: 13F20C0223 / (01)10801902121285(17)220228(10)13F20C0223, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19M0954; Code PT-03000, Lot number 13C20A0627; Code PT-01000-D, Lot number 13C20B2334; Lot Number / UDI: 13F20C0593 / (01)10801902121285(17)220331(10)13F20C0593, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-65509-S, Lot number 14C20C0858; Code PT-03000, Lot number 13C20A0627; Code PT-01000-D, Lot number 13C20B2334; Code PT-01000-D, Lot number 13C20C1557; Lot Number / UDI: 13F20D0128 / (01)10801902121285(17)220331(10)13F20D0128, Components: Code PT-65509-S, Lot number 14C20C0858; Code PT-65509-S, Lot number 14C20D0475; Code PT-03000, Lot number 13C20B0812; Code PT-01000-D, Lot number 13C20C1557; Code PT-01000-D, Lot number 13C20D1155; Lot Number / UDI: 13F20D0386 / (01)10801902121285(17)220331(10)13F20D0386, Components: Code PT-65509-S, Lot number 14C20D0475; Code PT-03000, Lot number 13C20C2655; Code PT-01000-D, Lot number 13C20D1155; Code PT-01000-D, Lot number 13C20D0848; Lot Number / UDI: 13F20F0576 / (01)10801902121285(17)220630(10)13F20F0576, Components: Code PT-65509-S, Lot number 14C20D0475; Code PT-65509-S, Lot number 14C20E0949; Code PT-03000, Lot number 13C20D1154; Code PT-01000-D, Lot number 13C20E0897; Lot Number / UDI: 13F20G0176 / (01)10801902121285(17)220630(10)13F20G0176, Components: Code PT-65509-S, Lot number 14C20E0949; Code PT-03000, Lot number 13C20G0231; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20G0235; Lot Number / UDI: 13F20J0139 / (01)10801902121285(17)220831(10)13F20J0139, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-65509-S, Lot number 14C20E0949; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20G035; Code PT-01000-D, Lot number 13C20G1571; Lot Number / UDI: 13F20J0547 / (01)10801902121285(17)220831(10)13F20J0547, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-03000, Lot number 13C20G1570; Code PT-03000, Lot number 13C20J0904; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20H2329; Code PT-01000-D, Lot number 13C20G1571; Lot Number / UDI: 13F20K0212 / (01)10801902121285(17)220930(10)13F20K0212, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-03000, Lot number 13C20J0904; Code PT-01000-D, Lot number 13C20H2329; Code PT-01000-D, Lot number 13C20E0897; Lot Number / UDI: 13F20L0160 / (01)10801902121285(17)221031(10)13F20L0160, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-03000, Lot number 13C20J2204; Code PT-01000-D, Lot number 13C20K0550; Code PT-01000-D, Lot number 13C20H2329; Code , Lot number; Lot Number / UDI: 13F20M0183 / (01)10801902121285(17)22123(10)13F20M0183, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-65509-S, Lot number 14C20K1044; Code PT-03000, Lot number 13C20J09904; Code PT-03000, Lot number 13C20J2204; Code PT-03000, Lot number 13C20K2183; Code PT-03000, Lot number 13C20L1808; Code PT-01000-D, Lot number 13C20K0550; Code PT-01000-D, Lot number 13C20H2329; Code PT-01000-D, Lot number 13C20M0603; Lot Number / UDI: 13F21B0224 / (01)10801902121285(17)230131(10)13F21B0224, Components: Code PT-65509-S, Lot number 14C20K1044; Code PT-65509-S, Lot number 14C20M0931; Code PT-03000, Lot number 13C20J0904; Code PT-03000, Lot number 13C20M0145; Code PT-03000, Lot number 13C21A0856; Code PT-03000, Lot number 13C20L1808; Code PT-01000-D, Lot number 13C20M0603; Code PT-01000-D, Lot number 13C20M0603; Code PT-01000-D, Lot number 13C20H2329; Lot Number / UDI: 13F21C0080 / (01)10801902121285(17)230228(10)13F21C0080, Components: Code PT-65509-S, Lot number 14C20M0931; Code PT-65509-S, Lot number 14C21B0685; Code PT-03000, Lot number 13C20M0145; Code PT-03000, Lot number 13C21A0856; Code PT-03000, Lot number 13C21B0561; Code PT-01000-D, Lot number 13C21B0563; Code PT-01000-D, Lot number 13C20H2329; Lot Number / UDI: 13F21C0366 / (01)10801902121285(17)230228(10)13F21C0366, Components: Code PT-65509-S, Lot number 14C20M0931; Code PT-65509-S, Lot number 14C21B0685; Code PT-03000, Lot number 13C21A0856; Code PT-01000-D, Lot number 13C21B0563; Code PT-01000-D, Lot number 13C20H2329; Lot Number / UDI: 13F21D0106 / (01)10801902121285(17)230331(10)13F21D0106, Components: Code PT-65509-S, Lot number 14C21B0685; Code PT-03000, Lot number 13C21A0856; Code PT-03000, Lot number 13C21B0561; Code PT-03000, Lot number 13C21C2403; Code PT-01000-D, Lot number 13C21C1154; Code PT-01000-D, Lot number 13C21B0563; Code PT-01000-D, Lot number 13C20H2329; Lot Number / UDI: 13X21D0026 / (01)10801902121285(17)230430(10)13X21D0026, Components: Code PT-65509-S, Lot number 14C21B0685; Code PT-65509-S, Lot number 14X21D0004; Code PT-03000, Lot number 13X21D0011; Code PT-01000-D, Lot number 13C21C1154; Code PT-01000-D, Lot number 13X21D0010; Lot Number / UDI: 13F21E0078 / (01)10801902121285(17)230430(10)13F21E0078, Components: Code PT-65509-S, Lot number 14C21B0685; Code PT-65509-S, Lot number 14C21D0123; Code PT-03000, Lot number 13C21D1120; Code PT-01000-D, Lot number 13C21C1154; Code PT-01000-D, Lot number 13C21C1693; Lot Number / UDI: 13F21E0557 / (01)10801902121285(17)230630(10)13F21E0557, Components: Code PT-65509-S, Lot number 14C21D0123; Code PT-65509-S, Lot number 14C21E0930; Code PT-65509-S, Lot number 14C21D1205; Code PT-65509-S, Lot number 14C21F1318; Code PT-03000, Lot number 13C21E1975; Code PT-03000, Lot number 13C21D1120; Code PT-03000, Lot number 13C21E1463; Code PT-01000-D, Lot number 13C21C1154; Code PT-01000-D, Lot number 13C21E0333; Lot Number / UDI: 13F21G1344 / (01)10801902121285(17)230731(10)13F21G1344, Components: Code PT-65509-S, Lot number 14C21F1318; Code PT-65509-S, Lot number 14R21D0123; Code PT-65509-S, Lot number 14R21D1205; Code PT-03000, Lot number 13C21E1463; Code PT-03000, Lot number 13C21E1975; Code PT-01000-D, Lot number 13C21E0333; Code PT-01000-D, Lot number 13C21E1985; Lot Number / UDI: 13F21H0213 / (01)10801902121285(17)230731(10)13F21H0213, Components: Code PT-65509-S, Lot number 14R21D1205; Code PT-65509-S, Lot number 14R21D1205; Code PT-65509-S, Lot number 14R21E0930; Code PT-03000, Lot number 13C21G0966; Code PT-03000, Lot number 13C21E1975; Code PT-01000-D, Lot number 13C21G0965; Code PT-01000-D, Lot number 13C21E1985; Lot Number / UDI: 13F21H0659 / (01)10801902194081(17)230831(10)13F21H0659, Components: Code PT-65509-S2, Lot number 14C21H0977; Code PT-03000-S, Lot number 13C21H1235; Code PT-01000-D2, Lot number 13C21H1234; Lot Number / UDI: 13F21J0455 / (01)10801902194081(17)230930(10)13F21J0455, Components: Code PT-65509-S2, Lot number 14C21H0977; Code PT-03000-S, Lot number 13C21H1235; Code PT-03000-S, Lot number 13C21J0983; Code PT-01000-D2, Lot number 13C21H1234; Code PT-01000-D2, Lot number 13C21J0982; Lot Number / UDI: 13F21K0897 / (01)10801902194081(17)231031(10)13F21K0897, Components: Code PT-65509-S2, Lot number 14C21H1311; Code PT-65509-S2, Lot number 14C21H0977; Code PT-03000-S, Lot number 13C21J0983; Code PT-01000-D2, Lot number 13C21J0982; Code PT-01000-D2, Lot number 13C21K1835; Lot Number / UDI: 13F21L0901 / (01)10801902194081(17)231130(10)13F21L0901, Components: Code PT-65509-S2, Lot number 14C21H1311; Code PT-65509-S2, Lot number 14C21K0161; Code PT-03000-S, Lot number 13C21J0983; Code PT-03000-S, Lot number 13C21K2035; Code PT-03000-S, Lot number 13C21L1102; Code PT-01000-D2, Lot number 13C21L1104
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: TELEFLEX MEDICAL INC
Reason for Recall:: The firm received reports indicating PTD tip separation during use.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

Lot Number / UDI: 13F20A0359 / (01)10801902121285(17)211231(10)13F20A0359, Components: Code PT-65509-S, Lot number 14C19H0644; Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19J0203; Code PT-01000-D, Lot number 13C19L2034; Lot Number / UDI: 13F20A0519 / (01)10801902121285(17)211131(10)13F20A0519, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19J0203; Code PT-03000, Lot number 13C19M0279; Code PT-01000-D, Lot number 13C20A0986; Lot Number / UDI: 13F20B0140 / (01)10801902121285(17)220131(10)13F20B0140, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19M0279; Code PT-03000, Lot number 13C19M0954; Code PT-01000-D, Lot number 13C20A2408; Lot Number / UDI: 13F20B0423 / (01)10801902121285(17)220228(10)13F20B0423, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19M0954; Code PT-03000, Lot number 13C20A0627; Code PT-01000-D, Lot number 13C20B1758; Lot Number / UDI: 13F20C0223 / (01)10801902121285(17)220228(10)13F20C0223, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-03000, Lot number 13C19M0954; Code PT-03000, Lot number 13C20A0627; Code PT-01000-D, Lot number 13C20B2334; Lot Number / UDI: 13F20C0593 / (01)10801902121285(17)220331(10)13F20C0593, Components: Code PT-65509-S, Lot number 14C19L1402; Code PT-65509-S, Lot number 14C20C0858; Code PT-03000, Lot number 13C20A0627; Code PT-01000-D, Lot number 13C20B2334; Code PT-01000-D, Lot number 13C20C1557; Lot Number / UDI: 13F20D0128 / (01)10801902121285(17)220331(10)13F20D0128, Components: Code PT-65509-S, Lot number 14C20C0858; Code PT-65509-S, Lot number 14C20D0475; Code PT-03000, Lot number 13C20B0812; Code PT-01000-D, Lot number 13C20C1557; Code PT-01000-D, Lot number 13C20D1155; Lot Number / UDI: 13F20D0386 / (01)10801902121285(17)220331(10)13F20D0386, Components: Code PT-65509-S, Lot number 14C20D0475; Code PT-03000, Lot number 13C20C2655; Code PT-01000-D, Lot number 13C20D1155; Code PT-01000-D, Lot number 13C20D0848; Lot Number / UDI: 13F20F0576 / (01)10801902121285(17)220630(10)13F20F0576, Components: Code PT-65509-S, Lot number 14C20D0475; Code PT-65509-S, Lot number 14C20E0949; Code PT-03000, Lot number 13C20D1154; Code PT-01000-D, Lot number 13C20E0897; Lot Number / UDI: 13F20G0176 / (01)10801902121285(17)220630(10)13F20G0176, Components: Code PT-65509-S, Lot number 14C20E0949; Code PT-03000, Lot number 13C20G0231; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20G0235; Lot Number / UDI: 13F20J0139 / (01)10801902121285(17)220831(10)13F20J0139, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-65509-S, Lot number 14C20E0949; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20G035; Code PT-01000-D, Lot number 13C20G1571; Lot Number / UDI: 13F20J0547 / (01)10801902121285(17)220831(10)13F20J0547, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-03000, Lot number 13C20G1570; Code PT-03000, Lot number 13C20J0904; Code PT-01000-D, Lot number 13C20E0897; Code PT-01000-D, Lot number 13C20H2329; Code PT-01000-D, Lot number 13C20G1571; Lot Number / UDI: 13F20K0212 / (01)10801902121285(17)220930(10)13F20K0212, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-03000, Lot number 13C20J0904; Code PT-01000-D, Lot number 13C20H2329; Code PT-01000-D, Lot number 13C20E0897; Lot Number / UDI: 13F20L0160 / (01)10801902121285(17)221031(10)13F20L0160, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-03000, Lot number 13C20J2204; Code PT-01000-D, Lot number 13C20K0550; Code PT-01000-D, Lot number 13C20H2329; Code , Lot number; Lot Number / UDI: 13F20M0183 / (01)10801902121285(17)22123(10)13F20M0183, Components: Code PT-65509-S, Lot number 14C20G0394; Code PT-65509-S, Lot number 14C20K1044; Code PT-03000, Lot number 13C20J09904; Code PT-03000, Lot number 13C20J2204; Code PT-03000, Lot number 13C20K2183; Code PT-03000, Lot number 13C20L1808; Code PT-01000-D, Lot number 13C20K0550; Code PT-01000-D, Lot number 13C20H2329; Code PT-01000-D, Lot number 13C20M0603; Lot Number / UDI: 13F21B0224 / (01)10801902121285(17)230131(10)13F21B0224, Components: Code PT-65509-S, Lot number 14C20K1044; Code PT-65509-S, Lot number 14C20M0931; Code PT-03000, Lot number 13C20J0904; Code PT-03000, Lot number 13C20M0145; Code PT-03000, Lot number 13C21A0856; Code PT-03000, Lot number 13C20L1808; Code PT-01000-D, Lot number 13C20M0603; Code PT-01000-D, Lot number 13C20M0603; Code PT-01000-D, Lot number 13C20H2329; Lot Number / UDI: 13F21C0080 / (01)10801902121285(17)230228(10)13F21C0080, Components: Code PT-65509-S, Lot number 14C20M0931; Code PT-65509-S, Lot number 14C21B0685; Code PT-03000, Lot number 13C20M0145; Code PT-03000, Lot number 13C21A0856; Code PT-03000, Lot number 13C21B0561; Code PT-01000-D, Lot number 13C21B0563; Code PT-01000-D, Lot number 13C20H2329; Lot Number / UDI: 13F21C0366 / (01)10801902121285(17)230228(10)13F21C0366, Components: Code PT-65509-S, Lot number 14C20M0931; Code PT-65509-S, Lot number 14C21B0685; Code PT-03000, Lot number 13C21A0856; Code PT-01000-D, Lot number 13C21B0563; Code PT-01000-D, Lot number 13C20H2329; Lot Number / UDI: 13F21D0106 / (01)10801902121285(17)230331(10)13F21D0106, Components: Code PT-65509-S, Lot number 14C21B0685; Code PT-03000, Lot number 13C21A0856; Code PT-03000, Lot number 13C21B0561; Code PT-03000, Lot number 13C21C2403; Code PT-01000-D, Lot number 13C21C1154; Code PT-01000-D, Lot number 13C21B0563; Code PT-01000-D, Lot number 13C20H2329; Lot Number / UDI: 13X21D0026 / (01)10801902121285(17)230430(10)13X21D0026, Components: Code PT-65509-S, Lot number 14C21B0685; Code PT-65509-S, Lot number 14X21D0004; Code PT-03000, Lot number 13X21D0011; Code PT-01000-D, Lot number 13C21C1154; Code PT-01000-D, Lot number 13X21D0010; Lot Number / UDI: 13F21E0078 / (01)10801902121285(17)230430(10)13F21E0078, Components: Code PT-65509-S, Lot number 14C21B0685; Code PT-65509-S, Lot number 14C21D0123; Code PT-03000, Lot number 13C21D1120; Code PT-01000-D, Lot number 13C21C1154; Code PT-01000-D, Lot number 13C21C1693; Lot Number / UDI: 13F21E0557 / (01)10801902121285(17)230630(10)13F21E0557, Components: Code PT-65509-S, Lot number 14C21D0123; Code PT-65509-S, Lot number 14C21E0930; Code PT-65509-S, Lot number 14C21D1205; Code PT-65509-S, Lot number 14C21F1318; Code PT-03000, Lot number 13C21E1975; Code PT-03000, Lot number 13C21D1120; Code PT-03000, Lot number 13C21E1463; Code PT-01000-D, Lot number 13C21C1154; Code PT-01000-D, Lot number 13C21E0333; Lot Number / UDI: 13F21G1344 / (01)10801902121285(17)230731(10)13F21G1344, Components: Code PT-65509-S, Lot number 14C21F1318; Code PT-65509-S, Lot number 14R21D0123; Code PT-65509-S, Lot number 14R21D1205; Code PT-03000, Lot number 13C21E1463; Code PT-03000, Lot number 13C21E1975; Code PT-01000-D, Lot number 13C21E0333; Code PT-01000-D, Lot number 13C21E1985; Lot Number / UDI: 13F21H0213 / (01)10801902121285(17)230731(10)13F21H0213, Components: Code PT-65509-S, Lot number 14R21D1205; Code PT-65509-S, Lot number 14R21D1205; Code PT-65509-S, Lot number 14R21E0930; Code PT-03000, Lot number 13C21G0966; Code PT-03000, Lot number 13C21E1975; Code PT-01000-D, Lot number 13C21G0965; Code PT-01000-D, Lot number 13C21E1985; Lot Number / UDI: 13F21H0659 / (01)10801902194081(17)230831(10)13F21H0659, Components: Code PT-65509-S2, Lot number 14C21H0977; Code PT-03000-S, Lot number 13C21H1235; Code PT-01000-D2, Lot number 13C21H1234; Lot Number / UDI: 13F21J0455 / (01)10801902194081(17)230930(10)13F21J0455, Components: Code PT-65509-S2, Lot number 14C21H0977; Code PT-03000-S, Lot number 13C21H1235; Code PT-03000-S, Lot number 13C21J0983; Code PT-01000-D2, Lot number 13C21H1234; Code PT-01000-D2, Lot number 13C21J0982; Lot Number / UDI: 13F21K0897 / (01)10801902194081(17)231031(10)13F21K0897, Components: Code PT-65509-S2, Lot number 14C21H1311; Code PT-65509-S2, Lot number 14C21H0977; Code PT-03000-S, Lot number 13C21J0983; Code PT-01000-D2, Lot number 13C21J0982; Code PT-01000-D2, Lot number 13C21K1835; Lot Number / UDI: 13F21L0901 / (01)10801902194081(17)231130(10)13F21L0901, Components: Code PT-65509-S2, Lot number 14C21H1311; Code PT-65509-S2, Lot number 14C21K0161; Code PT-03000-S, Lot number 13C21J0983; Code PT-03000-S, Lot number 13C21K2035; Code PT-03000-S, Lot number 13C21L1102; Code PT-01000-D2, Lot number 13C21L1104