Health product recall

Arrow-Trerotola Products

Last updated

Summary

Product
Arrow-Trerotola Products
Issue
Medical devices - Quality issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or serial number

Model or catalog number

Arrow-Trerotola Percutaneous Thrombolytic Device Rotator Drive Unit

13F20D0386, 13F20M0183, 13F21G1344, 13F20G0176, 13F20A0359, 13F20B0140, 13F20J0139, 13F21H0213, 13F21B0224, 13F21C0366, 13F20F0576, 13F20J0547, 13F21E0078, 13F20C0593

PT-65509-HFC

Arrow-Trerotola Percutaneous Thrombolytic Device Kit

13F20J0545, 13F21G0226, 13F20D0127, 13F20A0209, 13F21C0365, 13F20C0427, 13F20D0402, 13F20G0285

PT-45509, PT-65509

Arrow-Trerotola Over-The-Wire Ptd Kit

13F20G0284, 13F20B0053, 13F20C0094, 13F20G0361, 13F21C0748, 13F20G0566, 13F21C0080, 13F20F0577, 13F21A0354, 13F20H0756, 13F20F0578, 13F20F0230, 13F21A0353, 13F21E0415, 13F20L0282, 13F20A0323, 13F20M0182, 13F20L0514, 13F20C0596, 13F21C0747, 13F20B0139, 13F20K0849, 13F20L0283

PT-12709-WC, PT-65709-WC, PT-65709-WC, PT-65709-HFWC, PT-65709-W

Issue

Teleflex is initiating a voluntary field safety corrective action due to reports received indicating PTD tip separation during use. If the tip separates during use, clinicians may exercise their medical judgment to either retrieve endovascularly with a snare device or with a minor surgical procedure, or elect not to retrieve the tip given the recognition that embolism of a small and inert tip may be less likely to be harmful than extraordinary attempts to retrieve said tip. Partial or full embolization of foreign material into the arterial or venous circulation is possible, potentially leading to vascular complications, including but not limited to mechanical obstruction of an artery or vein, arterial or venous thrombosis, ischemia, or infarction in the territory subtended by an obstructed or thrombosed artery (including pulmonary embolism and infarction), and remotely, endovascular infection. the consequences of embolizing foreign material into the peripheral or pulmonary circulation or components thereof are substantially determined by the size of the embolus. Clinicians may also elect to exclude the embolus from the circulation by trapping the embolus outside a newly deployed stent.

Recall start date: Jan 12, 2022

Additional information

Details
Original published date: 2022-01-20
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Companies

Arrow International Llc Subsidiary Of Teleflex Incorporated

3015 Carrington Mill Blvd., Morrisville, North Carolina

United States, 27560

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63834