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U.S. Department of Health and Human Services

Class 2 Device Recall Cardiosave Hybrid IntraAortic Balloon Pump (IABP)

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  Class 2 Device Recall Cardiosave Hybrid IntraAortic Balloon Pump (IABP) see related information
Date Initiated by Firm September 08, 2021
Date Posted October 07, 2021
Recall Status1 Open3, Classified
Recall Number Z-0075-2022
Recall Event ID 88651
510(K)Number K112372  K151254  K163542  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
Code Information All lots
Recalling Firm/
Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information Contact Marylou Insinga
Manufacturer Reason
for Recall
The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.
FDA Determined
Cause 2
Device Design
Action On Wednesday, September 8, 2021, the firm distributed Urgent Medical Device Correction letters to affected customers. Customers were informed that all lots of Maquet Cardiosave Hybrid and Maquet Cardiosave Rescue experience the following issue: Helium Indicator Inaccuracy in the Presence of Continuous EMC Disturbances. Customers were provided with actions to take to limit the possibility of loss of therapy due to an over-reporting of remaining helium on the Helium Indicator. Cardiosave Hybrid users should view the mechanical gauge on the Cardiosave Top Panel to assess remaining helium capacity in case of suspected EMC disturbances. Cardiosave Rescue users should ensure the internal helium reservoir is full prior to use of the device. If the on-screen helium indicator is not showing full, fill the internal helium reservoir via the hospital cart or Helium Refilling Station. Please review the Cardiosave IABP Operation Transport Quick Reference Guide (0002-08-9772) for details on using the Cardiosave Rescue in transport. For both devices: Where practical maximize separation of Cardiosave system from other electronic equipment, communication devices and cables (e.g. power and communication cables). In particular, follow the recommended separation distances between communications equipment and the Cardiosave equipment as specified in the Cardiosave Operating instructions manual. The firm is developing a hardware correction to address this issue. A Datascope/Getinge service representative will contact customers to schedule the installation of the correction when available. The correction approximately will begin late Q2 2022. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in Commerce 5054 total (US), 5033 total (OUS)
Distribution Worldwide 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DSP and Original Applicant = CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
510(K)s with Product Code = DSP and Original Applicant = DATASCOPE CORP.