Class I Recall

Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T

Summary

The FDA issued a Class I for Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing by TELEFLEX MEDICAL INC. Reason: The firm received reports indicating PTD tip separation during use..

Details

Source

Device Recall

External ID

Z-0627-2022

Action Date

2022-02-23

Status

Terminated

Product Description

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.

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: Code PT-45509-S6, Lot number 14C20C1054; Code PT-45509-S6, Lot number 14C20D0569; Code PT-45509-T, Lot number 13C20E0902; Lot Number / UDI: 13F20G0285 / (01)10801902121261(17)220630(10)13F20G0285, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-S6, Lot number PT-45509-T; Code 13C20G0868, Lot Number / UDI: 13F20J0545 / (01)10801902121261(17)220831(10)13F20J0545, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-T, Lot number 13C20G1979; Lot Number / UDI: 13F20J0933 / (01)10801902121261(17)220930(10)13F20J0933, Components: Code PT-45509-S6, Lot number 14C20J1445; Code PT-45509-T, Lot number 13C20G1979; Code PT-45509-T, Lot number 13C20J1577; Lot Number / UDI: 13F20K0851 / (01)10801902121261(17)221031(10)13F20K0851, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-S6, Lot number 14C20J1445; Code PT-45509-T, Lot number 13C20G1979; Code PT-45509-T, Lot number 13C20J1577; Lot Number / UDI: 13F20M0174 / (01)10801902121261(17)221120(10)13F20M0174, Components: Code PT-45509-S6, Lot number 14C20K1177; Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-T, Lot number 13C20K1686; Code PT-45509-T, Lot number 13C20L1807; Lot Number / UDI: 13F21A0662 / (01)10801902121261(17)230131(10)13F21A0662, Components: Code PT-45509-S6, Lot number 14C20G0393; Code PT-45509-S6, Lot number 14C21A0480; Code PT-45509-T, Lot number 13C20K1686; Code PT-45509-T, Lot number 13C20L1807; Lot Number / UDI: 13F21C0079 / (01)10801902121261(17)230228(10)13F21C0079, Components: Code PT-45509-S6, Lot number 14C21A0480; Code PT-45509-T, Lot number 13C20J0354; Lot Number / UDI: 13F21C0751 / (01)10801902121261(17)230331(10)13F21C0751, Components: Code PT-45509-S6, Lot number 14C21A0480; Code PT-45509-S6, Lot number 14C21B0676; Code PT-45509-S6, Lot number 14C21C0477; Code PT-45509-T, Lot number 13C21C1697; Code PT-45509-T, Lot number 13C21B0771; Lot Number / UDI: 13X21D0027 / (01)10801902121261(17)230430(10)13X21D0027, Components: Code PT-45509-S6, Lot number 14X21D0003; Code PT-45509-S6, Lot number 14C21B0676; Code PT-45509-T, Lot number 13X21D0009; Lot Number / UDI: 13F21F0399 / (01)10801902121261(17)230531(10)13F21F0399, Components: Code PT-45509-S6, Lot number 14C21C0477; Code PT-45509-S6, Lot number 14C21D0675; Code PT-45509-T, Lot number 13C21E0717; Lot Number / UDI: 13F21G0226 / (01)10801902121261(17)230630(10)13F21G0226, Components: Code PT-45509-S6, Lot number 14C21C0477; Code PT-45509-S6, Lot number 14C21E0925; Code PT-45509-T, Lot number 13C21F2205; Lot Number / UDI: 13F21G1343 / (01)10801902121261(17)230731(10)13F21G1343, Components: Code PT-45509-S6, Lot number 14C21E0925; Code PT-45509-T, Lot number 13C21F2205; Lot Number / UDI: 13F21H0639 / (01)10801902121261(17)230731(10)13F21H0639, Components: Code PT-45509-S6, Lot number 14C21E0925; Code PT-45509-S6, Lot number 14C21G1307; Code PT-45509-T, Lot number 13C21H0942; Lot Number / UDI: 13F21H1272 / (01)10801902194067(17)230831(10)13F21H1272, Components: Code PT-45509-T2, Lot number 13C21H2037; Code PT-45509-S7, Lot number 14C21H0978; Lot Number / UDI: 13F21L0900 / (01)10801902194067(17)231130(10)13f21l0900, Components: Code PT-45509-T2, Lot number 13C21L1103; Code PT-45509-S7, Lot number 14C21H1310

Quantity Affected: 3668 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-01-11

Company

TELEFLEX MEDICAL INC

Morrisville, NC

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.

TELEFLEX MEDICAL INC has 9 FDA actions in our database, including 9 recalls.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TELEFLEX MEDICAL INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does TELEFLEX MEDICAL INC have FDA actions?

TELEFLEX MEDICAL INC has 9 FDA actions in our database, including 9 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0627-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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