# FDA recall Z-1928-2018

> **Maquet Datascope Corp - Cardiac Assist Division** · Class I · device recall initiated 2018-05-03.

## Product

CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179

## Reason for recall

Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy.

## Distribution

The devices were distributed to the following US states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Guam.    The devices were distributed to the following foreign countries: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Brunei, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Ghana, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nigeria, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrica, Taiwan, Thailand, Turkey, UAE, UK, Vietnam, Yemen.

## Key facts

- **Recall number:** Z-1928-2018
- **Recalling firm:** Maquet Datascope Corp - Cardiac Assist Division
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-05-03
- **Report date:** 2018-06-06

- **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-1928-2018

## Citation

> AI Analytics. FDA recall Z-1928-2018. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1928-2018. Source: US FDA. Licensed CC0.

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