The National Consumer Commission (NCC) has received a product recall of 103 units of EncoreTM 26 Inflation Device, EncoreTM 26 Advantage Kits, NephroMax Kits and UroMax Ultra Kits as notified by Boston Scientific. The devices were made available from 28 February 2025.
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 the manufacturer, the device is used in a variety of clinical applications, including interventional cardiology, neurovascular, endoscopy, urology, and peripheral vascular procedures.
Boston Scientific informed the NCC that they have discovered foreign material particles in the affected devices. 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 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.
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.
The NCC is monitoring this recall in terms of section 60 of the Consumer Protection Act.
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Issued by: National Consumer Commission (NCC)
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Phetho Ntaba (Spokesperson/MLO)
082 809 2031/012 065 2040