Urgent medical device recall issued for Boston Scientific products

Zuko Komisa

• The National Consumer Commission (NCC) has issued an urgent recall for several high-risk medical devices following notifications from Boston Scientific.
• The recall covers AXIOS stents and delivery systems, alongside POLARx cryoablation catheters and SMARTFREEZE consoles used in cardiac and endoscopic procedures.
• Specific AXIOS units are being withdrawn due to mechanical failures that may necessitate emergency surgical intervention to remove faulty components.

The National Consumer Commission (NCC) has alerted healthcare facilities and medical practitioners across South Africa regarding a significant product recall.

The primary concern involves the AXIOS stent and electrocautery-enhanced delivery system.

According to NCC spokesperson Pheto Ntaba, 128 units currently in the local market may suffer from deployment malfunctions.

The supplier has warned that the device’s first flange may fail to expand correctly during use. Such a failure typically occurs during the delivery phase and is likely to be spotted by the operating physician. However, these complications often lead to prolonged procedures or the need for secondary medical interventions, including the surgical removal of the device and the immediate closure of puncture sites.

In addition to the AXIOS range, the recall extends to several other specialised cardiac tools. This includes the POLARx and POLARx FIT cryoablation catheters, POLARSHEATH steerable sheaths, and SMARTFREEZE consoles. Medical professionals are advised to identify and isolate the affected batches immediately to prevent potential patient harm.

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