Recall notice: Boston Scientific recalls medical devices over safety concerns
The National Consumer Commission (NCC) has notified South African health facilities and medical practitioners about a recall of Boston Scientific medical devices.
Boston Scientific is recalling certain Axios Stent and Electrocautery Enhanced Delivery Systems, affecting 128 units in South Africa. Image credit: Boston Scientific
The product safety recall includes the Axios Stent and Electrocautery Enhanced Delivery System, as well as the Polarx and Polarx FIT Cryoablation Catheters, Polarsheath Steerable Sheaths, and Smartfreeze Consoles.
Boston Scientific is recalling certain Axios Stent and Electrocautery Enhanced Delivery Systems, affecting 128 units in South Africa.
According to the supplier, the affected devices may experience deployment issues.
In some cases, the first flange may fail to deploy or expand as intended, prolonging the procedure or requiring 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.
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 are part of a cardiac cryoablation system used to treat 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 under Section 60 of the Consumer Protection Act, Act 68 of 2008.