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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiosave

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 Class 2 Device Recall Cardiosavesee related information
Date Initiated by FirmDecember 23, 2016
Create DateMarch 02, 2017
Recall Status1 Terminated 3 on March 01, 2019
Recall NumberZ-1386-2017
Recall Event ID 76052
510(K)NumberK112372 K151254 
Product Classification System, balloon, intra-aortic and control - Product Code DSP
ProductCARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
Code Information part number 0146-00-0097
Recalling Firm/
Manufacturer		 Maquet Datascope Corp - Cardiac Assist Division
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information ContactKaren LeFevere
973-244-6138
Manufacturer Reason
for Recall		Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.
FDA Determined
Cause 2		Device Design
ActionMaquet contacted their customers via letter on 12/23/16 and additional customers identified were notified on 1/10/17 and issued a recall letter/return response form. The letter identified the affected product problem and actions to be taken. Customers were instructed to complete and return the response form via fax to 1-973-629-1518 or email to cardiosavebattery@getinge.com
Quantity in Commerce8000
DistributionWorldwide Distribution - US Nationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DSP
510(K)s with Product Code = DSP
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