It has come to our attention that medical device manufacturer, Biosensors, has initiated a field safety corrective action concerning its BioMatrix NeoFlex.
In specific production lots of the affected device, Biosensors has received reports of hub cracking prior to or during percutaneous coronary intervention procedures. This issue is related exclusively to the delivery system hub. Patients who have already been successfully implanted with an affected device are not impacted by this action. If not identified prior use, the hub cracking may potentially lead to treatment delays or complications. The manufacturer has determined that the hub cracks are associated with inconsistencies in the molding process by a single hub supplier during a limited time period in the first half of 2013.
The manufacturer advises users to identify, quarantine and return affected products.
According to the local supplier, the affected products were not distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 16 August 2013