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U.S. Department of Health and Human Services

Class 3 Device Recall Cardiosave Hybrid and Rescue Intra Aortic Balloon Pump

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  Class 3 Device Recall Cardiosave Hybrid and Rescue Intra Aortic Balloon Pump see related information
Date Initiated by Firm March 22, 2021
Date Posted April 28, 2021
Recall Status1 Open3, Classified
Recall Number Z-1506-2021
Recall Event ID 87482
510(K)Number K112372  K151254  K163542  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Cardiosave Hybrid IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 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 Systems. UDI: 10607567111117 10607567109008 10607567111940 10607567109107 10607567108421 10607567108438 10607567108391 10607567108414 10607567113432
Recalling Firm/
Manufacturer		 Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information Contact Marylou Insinga
973-709-7442
Manufacturer Reason
for Recall		 There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
FDA Determined
Cause 2		 Software design
Action URGENT MEDICAL DEVICE CORRECTION notification letters dated 3/22/21 were distributed to customers. PLEASE FORWARD THIS INFORMATION TO ALL CURRENT AND POTENTIAL CARDIOSAVE HYBRID and CARDIOSAVE RESCUE IABP USERS WITHIN YOUR HOSPITAL / FACILITY. IF YOU ARE A DISTRIBUTOR WHO HAS SHIPPED ANY AFFECTED PRODUCTS TO CUSTOMERS, PLEASE FORWARD THIS DOCUMENT TO THEIR ATTENTION FOR APPROPRIATE ACTION. Corrective Action: Datascope/Getinge is currently developing a software correction to address this issue. A Datascope/Getinge service representative will contact you to schedule the installation of the updated software. This work will be done at no cost to your facility. Please complete and sign the attached MEDICAL DEVICE CORRECTION RESPONSE FORM (page 5) to acknowledge that you have received this notification. Return the completed form to Datascope/Getinge by e-mailing a scanned copy to cardiosaveripple20.act@getinge.com or by faxing the form to 1-800-506-1644.
Quantity in Commerce 10087 total
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.
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