The Saudi Food and Drug Authority would like to notify physicians and healthcare practitioners about EXCOR® arterial cannula with graft CGRG-021
The Saudi Food and Drug Authority would like to notify physicians and healthcare practitioners about EXCOR® arterial cannula with graft CGRG-021
The Saudi Food and Drug Authority would like to notify physicians and healthcare practitioners about EXCOR® arterial cannula with graft CGRG-021
2012-11-25
The Saudi Food and Drug Authority would like to notify physicians and healthcare practitioners that the EXCOR® arterial cannula with graft CGRG-021(6 mm graft arterial cannula, all lot No.), which is used with Ventricular Assist Device System (VAD), has been recalled by Berlin Heart GmbH until further notice and their implantation may not take place, thus There is a risk for patients who are provided with the EXCOR" arterial cannula with graft CCRC-021 could experience seroma and bleeding, and as a result may require re-operation with a cannula exchange in individual cases. On the basis of this information the company Berlin Heart has decided to recall the EXCOR" arterial cannula with graft CCRC-021 from the market. All other arterial cannulae from the product range continue to be available without limitation and can be used for implantation..
Saudi Food and Drug Authority recommend all physicians and health care practitioners to adhere to the following :
- Until further notice the implantation of the EXCOR" arterial cannula with graft CGRG-021 shall not take place.
- Patients who are provided with the current EXCOR" arterial cannula with graft CCRC-021 shall be intensively clinically monitored regarding seroma and bleeding.
- Distribution and dissemination of information contained in this warning to all whom may concern.
Saudi Food and Drug Authority encourage all to report any adverse event associated with medical devices through the National Center for Medical Devices Reporting :
for more information please visit the Saudi Food and Drug Authority website :
