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U.S. Department of Health and Human Services

Class 2 Device Recall CARDIOSAVE IntraAortic Balloon Pump

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 Class 2 Device Recall CARDIOSAVE IntraAortic Balloon Pump see related information
Date Posted January 09, 2013
Recall Status1 Terminated on September 30, 2015
Recall Number Z-0662-2013
Recall Event ID 62121
510(K)Number K112372 
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product 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.
Code Information 510K K112372
Device Listing Number D132687


US Customer IABPs
CA202159K1
CA202167K1
CA203492L1
CA203494L1

International Customer IABPs
CA203486L1
CA202155K1
CA202161K1
CA203487L1
CA203490L1
CA203507L1
CA204330L1
CA204328L1
CA203505L1

International Company Owned IABPs

CA204327L1
CA202150K1
CA203506L1
CA204324L1
CA204326L1
CA202163K1
CA202169K!
CA203497L1
CA203498L1
CA203496L1
CA203503L1
CA203488L1
CA203493L1
CA203508L1
CA204337L1
CA203502L1
Recalling Firm/
Manufacturer
Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact Ms. Susan Mandy
973-709-7498
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
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 questions regarding this recall call 973-709-7498.
Quantity in Commerce 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
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) Database 510(K)s with Product Code = DSP and Original Applicant = CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
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