Recall Z-0662-2013 ยท DSP System, Balloon, Intra-Aortic And Control
Maquet Cardiovascular, LLC
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
| Date | Jan 9, 2013 (initiated Mar 27, 2012) |
| Status | Terminated |
| Reason | In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling. |
| Root cause | Device Design |
| Action | Maquet Cardiovascular sent an Urgent Product Recall Letter dated March 27, 2012, and Urgent Product Recall Acknowledgement to all affected customers . The letter identified the product, the problem, and the action to be taken by the customer. Datascope Corp determined that the best course of action was to replace the affected product. Customers were instructed that they would be contacted by a service representative to make arrangements for the removal and replacement of their affected product. Customers with questions were instructed to contact the US Call Center at 1-800-777-4222. For q |
| Quantity | 29 units (total) |
| Distribution | Worldwide Distribution - USA including ID and Fl and Internationally to United Arab Emirates, France, Luxembourg, Poland, Spain, Sweden, Germany, Italy, Netherlands, Republic of China, Spain, Sweden, and Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112372 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP Cardiac Assist, Maquet Cardiovascular, LLC, Sep 15, 2011 |