The National Consumer Commission (NCC) alerts health facilities and medical practitioners of product safety recalls of the AXIOS™ Stent and Electrocautery Enhanced Delivery System, as well as the POLARx™ and POLARx™ FIT Cryoablation Catheters, POLARSHEATH™ Steerable Sheaths, and SMARTFREEZE™ Consoles, as notified by Boston Scientific.
AXIOS™ STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Boston Scientific is recalling certain AXIOS™ Stent and Electrocautery Enhanced Delivery Systems (6 mm × 8 mm, 8 mm × 8 mm, and 20 mm × 10 mm), affecting 128 units in South Africa.
According to the supplier, the affected devices may experience difficulty during deployment. In some instances, the first flange may fail to deploy or expand as intended, which may result in prolongation of the procedure or the need for additional intervention, including endoscopic or surgical removal of the device and closure of the puncture site. The issue occurs at the point of device delivery and is expected to be identified by the treating physician during use.
POLARx™, POLARx™ FIT CRYOABLATION CATHETERS, POLARSHEATH™ STEERABLE SHEATHS AND SMARTFREEZE™ CONSOLES
Boston Scientific has also initiated a recall involving 63 affected units of the POLARx™ and POLARx™ FIT Cryoablation Balloon Catheters, POLARSHEATH™ Steerable Sheaths, and SMARTFREEZE™ Cryoablation System Consoles distributed in South Africa.
The affected devices form part of a cardiac cryoablation system used in the treatment of patients with paroxysmal atrial fibrillation. According to the supplier, the system is used for cryoablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI). The POLARx™ and POLARx™ FIT Cryoablation Balloon Catheters are single-use devices designed to ablate cardiac tissue, and are used together with the SMARTFREEZE™ Console, which delivers nitrous oxide refrigerant to achieve the required cryoablation temperatures.
Health facilities and medical practitioners in possession of the affected products are urged to immediately discontinue use, remove them from inventory, and segregate them in a secure location pending return to Boston Scientific.
The NCC is monitoring these recalls in terms of Section 60 of the Consumer Protection Act, Act 68 of 2008.
For questions or enquiries about this recall contact ProductRecall@thencc.org.za.
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