||January 09, 2013
|Recall Event ID
System, Balloon, Intra-Aortic And Control - Product Code DSP
||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.
Device Listing Number D132687
US Customer IABPs
International Customer IABPs
International Company Owned IABPs
|Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne, New Jersey 07470-2094
|For Additional Information Contact
||Ms. Susan Mandy
|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.
|DESIGN: Device Design
||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 questions regarding this recall call 973-709-7498.
|Quantity in Commerce
||29 units (total)
||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
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = DSP and Original Applicant = CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC