The National Consumer Commission (NCC) alerts healthcare facilities and medical practitioners to the recall of certain Boston Scientific CRE Wireguided, CRE PRO Wireguided, and CRE PRO GI Wireguided Balloon Dilation Catheters as notified by Boston Scientific. A total of twenty-six (26) affected units have been identified in South Africa.

The affected devices are designed for use during endoscopic procedures to dilate strictures of the alimentary tract. The CRE PRO Wireguided Balloon Dilatation Catheters are also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.

According to Boston Scientific, the recall of CRE Wireguided, CRE PRO Wireguided, and CRE PRO GI Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged. These catheter products are primarily used to endoscopically dilate strictures of the alimentary tract. The most common adverse health consequence reasonably foreseeable to occur is a prolonged procedure of negligible severity to account for device exchange prior to the procedure. It is reasonable to expect that another of the same or a similar gastrointestinal dilatation balloon would be readily available for use as they are commonly stocked items in a facility where endoscopic procedures are performed.

Healthcare facilities, distributors and medical practitioners in possession of the affected products are advised to immediately discontinue use and remove all affected units from inventory.

Questions and queries relating to this recall may be directed to: ProductRecall@thencc.org.za.

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Issued by: National Consumer Commission (NCC) 

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