Datascope Corp.: Device Recall

Recall Details

Recall Number

Z-0931-2026

Classification

Class III

Product Type

Device

Recalling Firm

Datascope Corp.

Status

Ongoing

Date Initiated

10/23/2025

Location

Mahwah, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

11470 units (5095 US, 6375 OUS)

Reason for Recall

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

Product Description

Cardiosave Hybrid

Distribution Pattern

Domestic: Nationwide distribution. International: Albania, Algeria, Angola, Argentina, Armenia, Republic of, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Republic of, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d Ivoire, (Ivory Coast), Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mauritius, Mexico, Montenegro, Morocco, Myanmar, (Burma), 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, Republic Of China, Tanzania, United Republic Of, 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 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 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. →