Medical device manufacturer, Biosensors, has issued a medical device safety alert concerning its BioMatrix Flex and BioMatrix NeoFlex Coronary Drug Eluting Stent Systems.
The manufacturer is initiating a voluntary recall on certain units of BioMatrix Flex and BioMatrix NeoFlex Coronary Drug Eluting Stent System (DES) due to potential balloon burst below the rated burst pressure.
The manufacturer discovered during routine lot release testing that several production lots did not meet the balloon rated burst performance specifications. After full investigation, the manufacturer concludes that the compromised balloon performance was caused by certain characteristics in the manufacturing process. According to the manufacturer, the production lots manufactured between October to December 2015 could have been similarly affected.
The compromised balloon performance may potentially lead to delay in inflation or deflation of the balloon; or balloon burst when the balloon is inflated above the nominal pressure. This could result in procedural complications and lead to serious deterioration in the patient's state of health during percutaneous coronary intervention.
Patients who have already been implanted with an affected device are not impacted by this field safety corrective action.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 2 March 2016