The National Consumer Commission (NCC) has issued an urgent alert to health facilities and medical practitioners regarding a critical safety recall involving several medical devices manufactured by Boston Scientific, reports Cape {town} Etc.
This recall affects numerous units of highly specialised equipment designed for use in medical procedures across South Africa.
The recall, announced recently, highlights issues with the AXIOS™ Stent and Electrocautery Enhanced Delivery System, which includes specific sizes such as 6 mm x 8 mm, 8 mm x 8 mm, and 20 mm x 10 mm.
The NCC states that a total of 128 units of these devices are affected by the recall. According to the manufacturer, the devices may encounter difficulties during deployment, posing significant risks during medical procedures.
In serious instances, the first flange of the stent may fail to deploy or expand as intended. This malfunction can lead to prolongation of medical procedures and may necessitate additional interventions, including endoscopic or surgical removal of the device, as well as closure of the puncture site.
These complications can significantly impact patient safety and care outcomes.
Cape {town} Etc Discount Alert! Unlock Cape Town’s best experiences for half the price! From unforgettable adventures to hidden gems and mouthwatering restaurants, these limited-time deals won’t last long. Snag your discount before they’re gone!
In addition to the AXIOS™ devices, the NCC is also addressing the recall of 63 units of the POLARx™ and POLARx™ FIT Cryoablation Catheters, POLARSHEATH™ Steerable Sheaths, and SMARTFREEZE™ Cryoablation System Consoles that have been distributed throughout South Africa.
Medical practitioners using these devices are advised to review their inventories and ensure that affected products are not in use.
The NCC’s alert serves as a necessary reminder for healthcare professionals to maintain vigilant oversight over the medical devices employed in patient care.
The risks associated with deploying malfunctioning medical devices highlight the importance of ensuring that all equipment meets stringent safety standards and is functioning properly before any procedures are carried out.
Patients and healthcare providers are urged to contact Boston Scientific or their medical facilities immediately if they suspect that any of the recalled devices are in use.
Be the first to know – Join our WhatsApp Channel for content worth tapping into! Click here to join!
Also read:
NCC issues compliance notices to 45 shops over expired goods
