FDA Medical devices recall ·
Cardiosave Hybrid recall
- Recall number
- Z-0916-2026
- Date
- (initiated November 4, 2025)
- Company / brand
- Datascope Corp.
1300 Macarthur Blvd, Mahwah, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11,470 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Why was it recalled?
The IFU addendum revises the Preventative Maintenance schedule to align with the update introduced in the Service Manual as of June 2023.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. (UDI): D998-00-0800-31 (10607567109053), D998-00-0800-32 (10607567111117), D998-00-0800-33 (10607567109008), D998-00-0800-35 (10607567109107), D998-00-0800-36 (10607567114187), D998-00-0800-45 (10607567108421), D998-00-0800-52 (10607567108438), D998-00-0800-53 (10607567108391), D998-00-0800-55 (10607567108414), D998-00-0800-65 (10607567113432), D998-UC-0800-31 (10607567109053), D998-UC-0800-33 (10607567109008), D998-UC-0800-52 (10607567108438), D998-UC-0800-53 (10607567108391), D998-UC-0800-55 (10607567108414); ALL SERIAL NO.
Distribution
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0916-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.