# FDA recall Z-2149-2023

> **Datascope Corp.** · Class I · device recall initiated 2023-06-05.

## 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  0998-00-0800-45  0998-00-0800-52  0998-00-0800-53  0998-00-0800-55  0998-00-0800-65    0998-UC-0800-31*  0998-UC-0800-33*  0998-UC-0800-52*  0998-UC-0800-53*  0998-00-0800-55*    *Not US distribution

## Reason for recall

IABP may lose the ability to charge batteries in one or both bay slots.    Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC  power. Low battery alarms may alert the User to the issue prior to interruption of therapy.

## Distribution

Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: ALBANIA ALGERIA, 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, 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, UZ

## Key facts

- **Recall number:** Z-2149-2023
- **Recalling firm:** Datascope Corp.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-05
- **Report date:** 2023-07-26

- **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-2149-2023

## Citation

> AI Analytics. FDA recall Z-2149-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2149-2023. Source: US FDA. Licensed CC0.

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