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U.S. Department of Health and Human Services

Class 1 Device Recall Cardiosave Hybrid

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  Class 1 Device Recall Cardiosave Hybrid see related information
Date Initiated by Firm July 31, 2023
Date Posted August 30, 2023
Recall Status1 Open3, Classified
Recall Number Z-2431-2023
Recall Event ID 92501
510(K)Number K181122  
Product Classification System, balloon, intra-aortic and control - Product Code DSP
Product Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
Code Information All Lot Numbers. Model: 0998-00-0800-31, UDI: 10607567109053; Model: 0998-UC-0800-31, UDI: N/A; Model: 0998-00-0800-32,UDI: 10607567111117; Model: 0998-00-0800-33, UDI: 10607567109008; Model: 0998-UC-0800-33, UDI: N/A; Model: 0998-00-0800-34, UDI: 10607567111940; Model: 0998-00-0800-35, UDI: 10607567109107; Model: 0998-00-0800-45, UDI: 10607567108421;Model: 0998-00-0800-52, UDI: 10607567108438; Model: 0998-UC-0800-52, UDI: N/A; Model: 0998-00-0800-53, UDI:10607567108391; Model: 0998-UC-0800-53, UDI: N/A; Model: 0998-00-0800-55, UDI: 10607567108414; Model: 0998-UC-0800-55,UDI: N/A; Model: 0998-00-0800-65, UDI: 10607567113432; Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449
Recalling Firm/
Datascope Corp.
1300 Macarthur Blvd
Mahwah NJ 07430-2052
For Additional Information Contact Allison Jean Kaplan
Manufacturer Reason
for Recall
Users were reporting that the device was not charging as expected. It was discovered that users were unaware that the Cardiosave console was not completely inserted into the hospital cart. If the console is not fully inserted back into the cart the battery(ies) will not charge.
FDA Determined
Cause 2
Under Investigation by firm
Action An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/23 was sent to customers. Docking/Power Battery Failure User Actions to be taken now: Our records indicate that you may have a Cardiosave Hybrid and/or Cardiosave Rescue Intra- Aortic Balloon Pump (IABP) in your facility. Please examine your inventory immediately to determine if you have any Cardiosave Hybrid and/or Rescue IABPs. The Cardiosave device has two operating modes: Hybrid (docked within the hospital cart) and Rescue (transport). When in Hybrid mode the IABP may operate on both AC power and battery power; and when plugged in (AC power) can charge inserted batteries. When in Rescue (transport) mode, the IABP can operate on battery power, or AC Power with the use of the Transport Power Supply accessory (occupying a battery bay). However, unless the Cardiosave is powered off, the Transport Power Supply will not charge a battery inserted into the alternate battery bay unless the Transport Power Supply is connected directly to AC power. There are two methods where the IABP can be in transport/rescue mode without user intent: 1) The Cardiosave Hospital Cart's release latch has been released and the IABP console is not properly installed in the cart. 2) The IABP console is inserted into the hospital cart, but is not fully latched into the cart In both cases, information is provided to the user that the system is not in Hybrid mode via the Rescue Mode Icon on the bottom Cardiosave screen (top center of the screen). In addition, the battery in use message will be displayed in the informational message area even if the AC power cord is plugged in. Additionally, in both scenarios, the Cardiosave will not receive AC power and if the device is in operation, it will continue to operate on battery. When the Cardiosave is not receiving AC power, the batteries are unable to charge. If the AC Plug Icon is not present and/or the Rescue Icon is present, release the latch on the Hospital Cart located b
Quantity in Commerce 9175 units
Distribution Worldwide - 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 = Datascope Corp.