# FDA recall Z-1939-2019

> **Datascope Corp.** · Class I · device recall initiated 2019-06-17.

## Product

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53  For cardiovascular use.

## Reason for recall

Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed.  Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall.

## Distribution

Worldwide distribution. US Nationwide, AFGHANISTAN , HUNGARY , PANAMA , ALGERIA , ICELAND , PARAGUAY , ARGENTINA , INDIA , PERU , AUSTRALIA , INDONESIA , PHILIPPINES , AUSTRIA , IRAN , POLAND , AZERBAIJAN , IRAQ , PORTUGAL , BAHRAIN , IRELAND , QATAR , BANGLADESH , ISRAEL , ROMANIA , BELARUS , ITALY , RUSSIA , BELGIUM , JAPAN , SAUDI ARABIA , BOLIVIA , JORDAN , SERBIA , BOSNIA AND HERZEGOVINA , KAZAKHSTAN , SINGAPORE , BRAZIL , KENYA , SLOVAKIA , BRUNEI , KOSOVO , SLOVENIA , BULGARIA , KUWAIT , SOUTH AFRICA , CAMBODIA , LATVIA , SOUTH KOREA , CANADA , LEBANON , SPAIN , CHILE , LIBYA , SRI LANKA , CHINA , LITHUANIA , SWEDEN , COLOMBIA , LUXEMBOURG , SWITZERLAND , COSTA RICA , MACAU , SYRIA , CROATIA , MACEDONIA , TAIWAN , CYPRUS , MALAYSIA , TANZANIA , CZECH REPUBLIC , MALDIVES , THAILAND , DENMARK , MALTA , TRINIDAD , DOMINICAN REP , MARTINIQUE , TUNISIA , ECUADOR , MAURITIUS , TURKEY , EGYPT , MEXICO , TURKMENISTAN , EL SALVADOR , MOROCCO , UGANDA , ESTONIA , MYANMAR , UKRAINE , FINLA

## Key facts

- **Recall number:** Z-1939-2019
- **Recalling firm:** Datascope Corp.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-06-17
- **Report date:** 2019-07-24

- **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-1939-2019

## Citation

> AI Analytics. FDA recall Z-1939-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1939-2019. Source: US FDA. Licensed CC0.

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