Z-0885-2023 Class I Ongoing
FDA device recall Z-0885-2023 was initiated by Datascope Corp. on Dec 19, 2022 and is designated Class I. Reason for recall: The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter. The recall status is ongoing. Affected quantity: 11,906 Total.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 25, 2023
- Initiation Date
- Dec 19, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,906 Total
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Albania, Angola, Argentina, Australia, Austria, AZERBAIJAN, BAHRAIN, BANGLADESH, Barbados, Belarus, Belgium, BOSNIA and HERZEGOVINA, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, C¿te d'Ivoire, Croatia, CZECH REPUBLIC, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, TRINIDAD AND TOBAGO, Tunisia, Turkey, Turkmenistan, Ukraine, UNITED ARAB EMIRATES, United Kingdom, Vietnam, Yemen, and Zambia.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0885-2023
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026