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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

Datascope Corp.: Cardiosave Balloon Pumps Recalled Due to Battery Charging Failure

Agency Publication Date: August 30, 2023
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Summary

Datascope Corp. has recalled approximately 18,350 Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) because the device console may not fully insert into its hospital cart. If the console is not completely docked, the internal batteries will fail to charge, leading to an unexpected loss of therapy if the unit is unplugged from a wall outlet. There have been reports from users that the device was not charging as expected because they were unaware the console was not fully seated. These devices are critical for heart support and were distributed nationwide and worldwide.

Risk

The failure to fully insert the console into the cart prevents battery charging, which can cause the pump to shut down without warning during patient transport or a power outage. This sudden loss of life-sustaining circulatory support poses a critical risk of serious injury or death.

What You Should Do

  1. Identify if your facility uses Cardiosave Hybrid or Rescue Intra-Aortic Balloon Pumps with part numbers such as 0998-00-0800-31, 0998-00-0800-75, 0998-00-0800-83, or 0998-00-0800-85.
  2. Check all units immediately to ensure that the console is completely and securely inserted into the hospital cart assembly.
  3. Verify that the battery charging indicator light is active when the unit is docked to confirm a proper connection to power.
  4. Review the instructions provided in the firm's notification letter issued on July 31, 2023, regarding proper docking procedures.
  5. Contact Datascope Corp. (Getinge) at 1300 Macarthur Blvd, Mahwah, New Jersey, 07430-2052 for technical support if you encounter docking or charging issues.
  6. Contact your healthcare provider or hospital equipment manager if you have further questions about the safety of the device currently in use.
  7. For additional information, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Ensure proper console insertion into the hospital cart.

How to: Users must ensure the Cardiosave console is completely inserted into the hospital cart to enable battery charging. Contact the manufacturer for further instructions.

Affected Products

Product: Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP)
Model / REF:
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
UPC Codes:
10607567109053
10607567111117
10607567109008
10607567111940
10607567109107
10607567108421
10607567108438
10607567108391
10607567108414
10607567113432
10607567112312
10607567108407
10607567113449
Lot Numbers:
All Lot Numbers
Product: Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP)
Model / REF:
0998-00-0800-75
0998-00-0800-83
0998-00-0800-85
UPC Codes:
10607567112312
10607567108407
10607567113449
Lot Numbers:
All Lot Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92501
Status: Active
Manufacturer: Datascope Corp.
Sold By: Hospitals; Medical centers; Healthcare facilities
Manufactured In: United States
Units Affected: 2 products (9175 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.