Product Recall Notice

Argon Medical Devices, Inc. (“Argon”) has received complaints from customers regarding the TLAB Transjugular Liver Biopsy System for a potential defect of the 7F Introducer Sheath, where the distal tip can potentially separate during use if the tip is flexed or experiences lateral bending stresses. Argon has conducted an internal investigation and has determined that an error in the production process resulted in a small number of devices that could have this defect. Actions have already been identified and implemented to improve the process.

As a precautionary measure, Argon is conducting a recall to notify all customers of the potential separation of the 7F Introducer Sheath distal tip that is included in certain TLAB kits.

If you are in possession of a device listed below, please read the attached notice and reach out to Terumo Medical Canada Inc. for handling.