Datascope Corp.: Device Recall

Recall #Z-0311-2025 · 09/17/2024

Class II: Risk

Recall Details

Recall Number: Z-0311-2025
Classification: Class II
Product Type: Device
Recalling Firm: Datascope Corp.
Status: Ongoing
Date Initiated: 09/17/2024
Location: Fairfield, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 160 units

Reason for Recall

There is discrepant labeling on the inner and outer packaging of the device.

Product Description

MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

Distribution Pattern

International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.

Other Recalls by Datascope Corp.

Class II: Risk 11/04/2025

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

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

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

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Class I: Dangerous 08/08/2024

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.

View all recalls by Datascope Corp. →

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.