Is CS 100i Intra-Aortic Balloon Pump recalled?

Critical RiskFDA Device

Maquet Datascope Corp - Cardiac Assist Division: The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.

Agency Publication Date: June 23, 2017

Affected Products

Product: CS 100i Intra-Aortic Balloon Pump

0998-UC-0446HXX 0998-UC-0479HXX

Product: CS 100 Intra-Aortic Balloon Pump

0998-XX-3013-XX, 0998-UC-3013-XX

Product: CS 300 Intra-Aortic Balloon Pump

0998-XX-3023-XX 0998-UC-3023-XX

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77566

Status: Resolved

Manufacturer: Maquet Datascope Corp - Cardiac Assist Division

Manufactured In: United States

Units Affected: 3 products (12,319 units total)

Agency Last Updated: November 29, 2019

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.