Is Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 recalled?

There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft. Status: Voluntary: Firm initiated Initial Firm Notification: Press Release Distribution: US Nationwide; Internationally to 77 countries

Critical RiskFDA Device

Maquet Datascope Corp - Cardiac Assist Division: There is a potential for interruption and/or inability to start therapy to the patient prior to or during use of Cardiosave IABP for users who are at altitudes above 3200 Ft.

Agency Publication Date: October 27, 2018

Affected Products

Product: Cardiosave Hybrid IABP, Part Number 0998-00-0800-53

UDI - 10607567108391 All Serial Numbers

Product: Cardiosave Rescue IABP, Part Number 0998-UC-0800-83

UDI - 10607567108407 All Serial Numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81055

Status: Active

Manufacturer: Maquet Datascope Corp - Cardiac Assist Division

Manufactured In: United States

Agency Last Updated: December 12, 2018

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.

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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 · 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.