# FDA recall Z-3087-2017

> **Maquet Datascope Corp - Cardiac Assist Division** · Class I · device recall initiated 2017-07-17.

## Product

CS 300 Intra-Aortic Balloon Pump.    It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.

## Reason for recall

False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.

## Distribution

Worldwide Distribution - US Nationwide   International: AFGHANISTAN, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA,  AZERBAIJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE,  CHINA, COLOMBIA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT,  EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY,  GREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY,  ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN,  JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA,  LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALDIVES, MALTA,  MAURITIUS, MEXICO, MOROCCO, MYANMAR, NEPAL, NETHERLANDS,  NEW ZEALAND, NORTH KOREA, NORWAY, OMAN, PAKISTAN, PALESTINE,  PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR,   ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN,  SWITZERLAND, SYRIA, TAIWA

## Key facts

- **Recall number:** Z-3087-2017
- **Recalling firm:** Maquet Datascope Corp - Cardiac Assist Division
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-07-17
- **Report date:** 2017-09-13

- **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-3087-2017

## Citation

> AI Analytics. FDA recall Z-3087-2017. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-3087-2017. Source: US FDA. Licensed CC0.

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