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Recall archive / FDA device enforcement

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, ... — FDA record Z-0885-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 19, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-32, 0998-UC-0800-33, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55, 0998-UC-0800-65.
Reason
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.
Classification
Class I
Recalling firm
Datascope Corp.
Quantity
11,906 Total
Agency-reported status
Ongoing
Source record identifier
Z-0885-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityAll Serial Numbers. May also be designated as part number D998 etc. Model Number, UDI-DI: 0998-00-0800-31, 10607567109053; 0998-00-0800-32, 10607567111117; 0998-00-0800-33, 10607567109053; 0998-00-0800-34, 10607567111940; 0998-00-0800-35, 10607567109107; 0998-00-0800-36, 10607567114187; 0998-00-0800-45, 10607567108421; 0998-00-0800-52, 10607567108438; 0998-00-0800-53, 10607567108391; 0998-00-0800-55, 10607567108414; 0998-00-0800-65, 10607567113432; 0998-UC-0800-31, 10607567109053; 0998-UC-0800-32, 10607567111117; 0998-UC-0800-33, 10607567109008; 0998-UC-0800-34, 10607567111940; 0998-UC-0800-35, 10607567109107; 0998-UC-0800-36, 10607567114187; 0998-UC-0800-45, 10607567108421; 0998-UC-0800-52, 10607567108438; 0998-UC-0800-53, 10607567108391; 0998-UC-0800-55, 10607567108414; 0998-UC-0800-65, 10607567113432.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Jan 25, 2023
Recall initiation date
Dec 19, 2022
Center classification date
Jan 19, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

Related records

Medical devices recordsDatascope Corp. records