The NCC is recalling certain AXIOS™ stent and electrocautery enhanced delivery systems.
Image: Boston Scientific
The National Consumer Commission (NCC) has sent out an alert to health facilities and medical practitioners, relating to a product recall of various devices. These include the AXIOS™ stent and electrocautery enhanced delivery System, as well as the POLARx™ and POLARx™ FIT cryoablation catheters, POLARSHEATH™ steerable sheaths, and SMARTFREEZE™ consoles.
This was after the NCC was notified of potential issues by Boston Scientific.
Boston Scientific is recalling certain AXIOS™ stents and electrocautery enhanced delivery systems, (6 mm × 8 mm, 8 mm × 8 mm, and 20 mm × 10 mm), affecting 128 units in South Africa.
POLARx™ FIT cryoablation balloon catheters.
Image: Boston Scientific
The NCC’s spokesperson, Pheto Ntaba, said that according to the supplier, the affected devices may experience difficulties 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,” Ntaba said.
POLARSHEATH™ steerable sheaths are part of the recall.
Image: Boston Scientific
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.
Paroxysmal atrial fibrillation is a condition characterised by temporary, recurring episodes of irregular, rapid heart rhythms that spontaneously start and stop within seven days.
“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,” Ntaba said.
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,” Ntaba said.
IOL has reached out to the NCC regarding the plan for devices already fitted to patients, but a response had not been received at the time of writing.
However, the FDA in the US said patients who have been treated with a successfully implanted AXIOS stent should continue to follow standard of care, as the issue only occurs at the time of delivery of the stent.
IOL