The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a medical device field safety notice concerning the following heart valves manufactured by Edward Lifesciences Ltd:-
Edwards decided to recall all unused devices with the above model numbers as they discovered that some of the valve jars containing the products may contain one or more small particles. The particles are metallic and were introduced into the valve jars during the packaging process.
Edwards commented that based on particle size (vast majority <200 microns in size), the small number of particles in any affected jar and the likelihood of the particles being removed during the rinse procedure described in the device's Direction for Use, the risk of injury to patients implanted with an affected device is unlikely.
According to the local distributor, affected products have been distributed in Hong Kong.
For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/index.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted 29 May 2012