Home / Recalls / Datascope Corp. / Z-0931-2026

Z-0931-2026 Class III Ongoing

Recalled by Datascope Corp. — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
December 24, 2025
Initiation Date
October 23, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11470 units (5095 US, 6375 OUS)

Product Description

Cardiosave Hybrid

Reason for Recall

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

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;

Code Information

1) Model: 0998-00-0800-31; UDI-DI: 10607567109053; Serial Numbers: All; 2) Model: 0998-00-0800-32; UDI-DI: 10607567111117; Serial Numbers: All; 3) Model: 0998-00-0800-33; UDI-DI: 10607567109008; Serial Numbers: All; 4)Model: 0998-00-0800-35; UDI-DI: 10607567109107; Serial Numbers: All; 5)Model: 0998-00-0800-36; UDI-DI: 10607567114187; Serial Numbers: All; 6)Model: 0998-00-0800-45; UDI-DI: 10607567108421; Serial Numbers: All; 7)Model: 0998-00-0800-52; UDI-DI: 10607567108438; Serial Numbers: All; 8)Model: 0998-00-0800-53; UDI-DI: 10607567108391; Serial Numbers: All; 9) Model: 0998-00-0800-55; UDI-DI: 10607567108414; Serial Numbers: All; 10) Model: 0998-00-0800-65; UDI-DI: 10607567113432; Serial Numbers: All; 11) Model: 0998-UC-0800-31; UDI-DI: 10607567109053; Serial Numbers: All; 12) Model: 0998-UC-0800-33; UDI-DI: 10607567109008; Serial Numbers: All; 13) Model: 0998-UC-0800-52; UDI-DI: 10607567108438; Serial Numbers: All; 14) Model: 0998-UC-0800-53; UDI-DI: 10607567108391; Serial Numbers: All; 15) Model: 0998-UC-0800-55; UDI-DI: 10607567108414; Serial Numbers: All;

Other recalls by Datascope Corp.

  • Z-1487-2026 Class II — CS300 IABP. Software Version CS300 IABP C.01. (January 23, 2026)
  • Z-1486-2026 Class II — CS100 IABP. Software Version CS100 IABP Q.01. (January 23, 2026)
  • Z-0916-2026 Class II — Cardiosave Hybrid. Intra-Aortic Balloon Pump system. (November 4, 2025)
  • Z-0917-2026 Class II — Cardiosave Rescue. Intra-Aortic Balloon Pump system. (November 4, 2025)
  • Z-0932-2026 Class III — Cardiosave Rescue (October 23, 2025)
  • Z-0311-2025 Class II — MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0 (September 17, 2024)
  • Z-3137-2024 Class I — CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use (August 8, 2024)
  • Z-3134-2024 Class I — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use (August 8, 2024)
  • Z-3136-2024 Class I — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use (August 8, 2024)
  • Z-3135-2024 Class I — CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system use (August 8, 2024)