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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-2433-2023
Recall Event ID 92498
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 reported "System Over Temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering Standby mode.
FDA Determined
Cause 2
Under Investigation by firm
Action An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/23 was sent to customers. System Over-Temperature 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. When a System Over Temperature alarm is triggered, the device must be powered down and allowed to cool to a safe operating internal temperature before therapy can be re-initiated using the same IABP. Should you experience a System Over Temperature of Cardiosave IABP during therapy, perform the following instructions documented in CARDIOSAVE Hybrid and Rescue, Operational Instruction for US and OUS: 1. Turn the IABP OFF by pressing and holding the green IABP Power Button, located on the back panel, for 2 seconds 2. Wait 10 seconds 3. Turn the IABP ON by pressing and releasing the green IABP Power Button If the alarm message persists, switch to another IABP if available and contact your Service representative. If another IABP console is not available for use, alternative means of providing hemodynamic support (vasopressors, inotropes or alternate therapies) may be initiated by a healthcare provider as a temporizing measure. Consideration should be given to having a backup IABP available in the event the IABP doesn t cool sufficiently to restart or the alarm reoccurs. To help prevent such alarms from occurring, ensure that there are no restrictions to the airflow around the Cardiosave device. Restrictions to the vents on the device can significantly increase the internal temperature of the device, leading to such temperature excursions. Additionally, as per CARDIOSAVE Hybrid and Rescue Operational Instruction, it is essential not to operate the Cardiosave device outside of the posted operating ambient ranges. This is to prevent such temperature excursions and ensure the safe and e
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.