The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom (UK) posted a field safety notice concerning EXCOR® arterial cannula with graft CGRG-021 manufactured by Berlin Heart GmbH.
During the period from October 2011 to July 2012, the EXCOR® arterial cannula with graft CGRG-021 (6 mm graft arterial cannula) was subject to a limited market launch with product monitoring. While evaluating the clinical data, Berlin Heart received an increasing number of cases in which, according to customer feedback, seroma and bleeding in the region of the graft material occurred. An analysis of the cause is in process.
There is the risk that for patients who are provided with the EXCOR® arterial cannula with graft CGRG-021 could experience seroma and bleeding, and as a result may require re-operation with a cannula exchange in individual case.
On the basis of this information, Berlin Heart has decided to recall the EXCOR® arterial cannula with graft CGRG-021 from the market. All other arterial cannulae from the product range continue to be available without limitation and can be used for implantations.
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 on 7 August 2012