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U.S. Department of Health and Human Services

Class 2 Device Recall Maquet CARDIOSAVE

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  Class 2 Device Recall Maquet CARDIOSAVE see related information
Date Initiated by Firm January 30, 2015
Date Posted February 23, 2015
Recall Status1 Terminated 3 on September 29, 2017
Recall Number Z-1140-2015
Recall Event ID 70510
510(K)Number K112372  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Code Information 0998-00-0800-31 0998-UC-0800-31 0998-00-0800-32 0998-UC-0800-33 0998-00-0800-33 0998-UC-0800-52 0998-00-0800-34 0998-UC-0800-53 0998-00-0800-35 0998-UC-0800-55 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55.   CARDIOSAVE Hybrid IABPs serviced with a new/replacement power supply after August 19, 2014 are not affected.
Recalling Firm/
Manufacturer		 Maquet Datascope Corp - Cardiac Assist Division
1300 MacArthur Blvd.
Mahwah NJ 07430-2052
For Additional Information Contact
800-777-4222
Manufacturer Reason
for Recall		 Power supply malfunction complaints related to suboptimal thermal management.
FDA Determined
Cause 2		 Under Investigation by firm
Action Maquet Inc. sent a recall letter/return response form dated 1/30/2015.
Quantity in Commerce 1,300 units
Distribution US Nationwide distribution
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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