Class 1 Device Recall ArrowTrerotola Percutaneous Thrombolytic Device

• Date Initiated by Firm: January 11, 2022
• Date Posted: February 15, 2022
• Recall Status: Terminated on September 11, 2024
• Recall Number: Z-0628-2022
• Recall Event ID: 89390
• 510(K)Number: K011056
• Product Classification: Peripheral mechanical thrombectomy with aspiration - Product Code QEW
• 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: TELEFLEX MEDICAL INC; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• Manufacturer Reason for Recall: The firm received reports indicating PTD tip separation during use.
• FDA Determined Cause: Process change control
• Action: Arrow International LLC/Teleflex notified their consignees by letter on 01/11/2022. The letter explained the issue and requested that the consignee cease use and distribution. Distributors were directed to notify their customers. The firm is seeking return of the affected product. The following instructions were provided: Action list number 1 Medical facilities 1. We request that you check your inventory for product within the scope of this FSCA. Users should cease use and distribution of impacted product and quarantine immediately. 2. If you do not have stock in scope of this FSCA mark the according checkbox on the Acknowledgement Form (Appendix 1) and return the form to the fax number or e-mail address mentioned below. 3. If you do have stock in scope of this FSCA, complete the Acknowledgement Form (Appendix 1) and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. Action list number 2 Distributors 1. Provide this field safety notice to all customers who have received product in scope of this FSCA. Your customer is then required to complete the Acknowledgement Form and return to you. 2. We request that you check your inventory for product within the scope of this FSCA. Cease use and distribution of impacted product and quarantine immediately. You may then return all product in scope to Teleflex. 3. As a distributor, you are then required to confirm to Teleflex that you have completed the field activity outlined above. Upon completion of your actions, please forward the completed Acknowledgement Form to Customer Service. Important - Please ensure you only list batch numbers in scope of this Field Safety Notice when completing this form. 4. If you have further distr
• Quantity in Commerce: 5530 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = QEW