Datascope Corp.: Device Recall

Recall #Z-0917-2026 · 11/04/2025

Class II: Risk

Recall Details

Recall Number: Z-0917-2026
Classification: Class II
Product Type: Device
Recalling Firm: Datascope Corp.
Status: Ongoing
Date Initiated: 11/04/2025
Location: Mahwah, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 47 units

Reason for Recall

The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.

Product Description

Cardiosave Rescue. Intra-Aortic Balloon Pump system.

Distribution Pattern

Domestic: Nationwide Distribution; Foreign: Albania, Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Palestine Territory, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen, Zambia.

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 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 II: Risk 09/17/2024

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