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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 Initiated by Firm March 27, 2012
Date Posting Updated January 09, 2013
Recall Status1 Terminated 3 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DSP and Original Applicant = CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
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