Consumer alert: Recall notice issued for certain Boston Scientific Encore medical devices and kits
The National Consumer Commission has urgently recalled specific Boston Scientific Encore medical devices after contamination was discovered.
Image: Julio César Velásquez Mejía /Pixabay
The National Consumer Commission (NCC) said it has received notice of a product recall of certain Boston Scientific Encore medical devices and kits after the manufacturer discovered foreign material particles in the products.
In a statement, the NCC said it had received a product recall of 103 units of Encore™ 26 Inflation Device, Encore™ 26 Advantage Kits, NephroMax Kits and UroMax Ultra Kits as notified by Boston Scientific. The affected devices were released from February 28 this year.
The commission spokesperson Pheto Ntaba explained that the “Encore 26 Inflation Device (including Kits) is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate it.”
According to Boston Scientific, the device is “used in a variety of clinical applications, including interventional cardiology, neurovascular, endoscopy, urology, and peripheral vascular procedures.”
The NCC said Boston Scientific had informed it that they have discovered foreign material particles in the affected devices.
The statement warned: “during use, these particles could migrate from the affected devices into a balloon dilation catheter, impacting the ability to inflate or deflate the balloon used with the Encore 26 inflation device.”
The NCC said this could have serious implications for patient care. “The inability to inflate may lead to a prolongation of the procedure, while deflation issues may require the balloon to be ruptured so that it can be removed from the patient,” it said.
The commission urged all health facilities in possession of the affected products to take immediate action.
“Health facilities in possession of the affected Encore inflation devices are urged to discontinue use of and segregate the affected product. Boston Scientific will collect the defective devices,” said Ntaba.
The NCC confirmed that it would be closely monitoring the recall process in line with consumer protection laws. “The NCC is monitoring this recall in terms of section 60 of the Consumer Protection Act,” Ntaba said.
The recall applies to specific units of the devices and kits, and no other Boston Scientific products are mentioned in the notice.
The NCC has called for cooperation from all relevant medical facilities to ensure that the defective devices are removed from use to prevent potential harm.