Class I Recall

Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65

Summary

The FDA issued a Class I for Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT- by TELEFLEX MEDICAL INC. Reason: The firm received reports indicating PTD tip separation during use..

Details

Source

Device Recall

External ID

Z-0624-2022

Action Date

2022-02-23

Status

Terminated

Product Description

Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS 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: 13F20A0323 / (01)108019022121292 (17)211231 (10)13F20A0323, Components: Code PT-65709-C, Lot number 13C19M0499; Code PT-65709-HFS, Lot number 14C19J0342; Code PT-03009, Lot number 13C19J1873; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C19J0572; Code PT-03009, Lot number 13C19K0832; Lot Number / UDI: 13F20B0139 / (01)10801902121292 (17)220131 (10)13F20B0139, Components: Code PT-65709-C, Lot number 13C20A0970; Code PT-65709-HFS, Lot number 14C20A0611; Code PT-65709-HFS, Lot number 14C19G0671; Code PT-03009, Lot number 13C19L0622; Lot Number / UDI: 13F20C0594 / (01)10801902121292 (17)220331 (10)13F20C0594, Components: Code PT-65709-C, Lot number 13C20C2082; Code PT-65709-HFS, Lot number 14C20A0611; Code PT-65709-HFS, Lot number 14C19J0342; Code PT-03009, Lot number 13C20B1435; Lot Number / UDI: 13F20F008 3/ (01)10801902121292 (17)220531 (10)13F20F0083, Components: Code PT-65709-C, Lot number 13C20F0572; Code PT-65709-HFS, Lot number 14C20D1060; Code PT-65709-HFS, Lot number 14C20A0611; Code PT-03009, Lot number 13C20C1558; Code PT-03009, Lot number 13C20B1435; Lot Number / UDI: 13F20F0230 / (01)10801902121292 (17)220531 (10)13F20F0230, Components: Code PT-65709-C, Lot number 13C20F1139; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-65709-HFS, Lot number 14C20D1060; Code PT-03009, Lot number 13C20F0570; Lot Number / UDI: 13F20F0577 / (01)10801902121292 (17)220630 (10)13F20F0577, Components: Code PT-65709-C, Lot number 13C20F2175; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-03009, Lot number 13C20F1138; Code PT-03009, Lot number 13C20F0570; Lot Number / UDI: 13F20H0756 / (01)10801902121292 (17)220831 (10)13F20H0756, Components: Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-HFS, Lot number 14C20F0274; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-03009, Lot number 13C20H0604; Code PT-03009, Lot number 13C20G1198; Lot Number / UDI: 13F20K0849 / (01)10801902121292 (17)221031 (10)13F20K0849, Components: Code PT-65709-C, Lot number 13C20H1675; Code PT-65709-C, Lot number 13C20G1976; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-65709-HFS, Lot number 14C20F0274; Code PT-03009, Lot number 13C20H0604; Lot Number / UDI: 13F20L0283 / (01)10801902121292 (17)221031 (10)13F20L0283, Components: Code PT-65709-C, Lot number 13C20H1675; Code PT-65709-C, Lot number 13C20J2689; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-65709-HFS, Lot number 14C20F0586; Code PT-03009, Lot number 13C20L0872; Lot Number / UDI: 13F20M0182 / (01)10801902121292 (17)221231 (10)13F20M0182, Components: Code PT-65709-C, Lot number 13C20J2689; Code PT-65709-C, Lot number 13C20H1675; Code PT-65709-HFS, Lot number 14C20L0665; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-03009, Lot number 13C20L0871; Lot Number / UDI: 13F21A0498 / (01)10801902121292 (17)221231 (10)13F21A0498, Components: Code PT-65709-C, Lot number 13C20M0639; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-03009, Lot number 13C21A0855; Lot Number / UDI: 13F21B0158 / (01)10801902121292 (17)230131 (10)13F21B0158, Components: Code PT-65709-C, Lot number 13C21A1348; Code PT-65709-HFS, Lot number 14C20M0932; Code PT-65709-HFS, Lot number 14C20L0665; Code PT-65709-HFS, Lot number 14C20J1446; Code PT-03009, Lot number 13C21A0855; Lot Number / UDI: 13F21C0747 / (01)10801902121292 (17)230331 (10)13F21C0747, Components: Code PT-65709-C, Lot number 13C21C0326; Code PT-65709-C, Lot number 13C21A1348; Code PT-65709-HFS, Lot number 14C20L0665; Code PT-65709-HFS, Lot number 14C20M0932; Code PT-03009, Lot number 13C21B1533; Lot Number / UDI: 13F21E0555 / (01)108019021212292 (17)230430 (10)13F21E0555, Components: Code PT-65709-C, Lot number 13C21E0328; Code PT-65709-C, Lot number 13C21D0717; Code PT-65709-C, Lot number 13C21C2412; Code PT-65709-HFS, Lot number 14C21C0895; Code PT-65709-HFS, Lot number 14C20M0932; Code PT-03009, Lot number 13C21C2413; Code PT-03009, Lot number 13C21C2397

Quantity Affected: 1400 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-0624-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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