Medical device manufacturer, Boston Scientific has issued a field safety corrective action regarding the recall of Z°Flex-270 Steerable Sheath (Catalogue number 7050). All Zo Flex-270 Steerable Sheaths are affected by this recall.
According to the manufacturer, the investigation of four complaints revealed that the internal PTFE liner was damaged during use which may post a potential embolic risk to the patients. No adverse events or patient injuries have been reported to date.
According to the local supplier, the affected products were not distributed in Hong Kong.
The manufacturer advised all users to immediately discontinue the use of the affected products.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 10 September 2012