Datascope Corp.

9 FDA enforcement actions

9 Total Recalls

4 Class I

3 Class II

2 Class III

Firm Details

Product Types: device
States: NJ

All Recalls

Class II: Risk 11/04/2025 device

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Class II: Risk 11/04/2025 device

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
Class III: Low Risk 10/23/2025 device

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Class III: Low Risk 10/23/2025 device

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Class II: Risk 09/17/2024 device

There is discrepant labeling on the inner and outer packaging of the device.
Class I: Dangerous 08/08/2024 device

Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Class I: Dangerous 08/08/2024 device

Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Class I: Dangerous 08/08/2024 device

Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
Class I: Dangerous 08/08/2024 device

Firm has developed a software correction (Revision D.01) for outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.