# FDA recall Z-0886-2023

> **Datascope Corp.** · Class I · device recall initiated 2022-12-19.

## Product

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.

## 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.

## 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, 

## Key facts

- **Recall number:** Z-0886-2023
- **Recalling firm:** Datascope Corp.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-19
- **Report date:** 2023-01-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0886-2023

## Citation

> AI Analytics. FDA recall Z-0886-2023. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0886-2023. Source: US FDA. Licensed CC0.

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