# FDA recall Z-1022-2023

> **SynCardia Systems LLC** · Class II · device recall initiated 2022-11-02.

## Product

SynCardia Total Artificial Heart System (70CC): 500101-001    SynCardia Total Artificial Heart System (50CC): 570500-000

## Reason for recall

Due to tears reported tears in the cannula due to wear and tear stress.

## Distribution

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, IA. IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI. The countries of Australia, Austria, Canada, Croatia, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lebanon, Lithuania, Macedonia, Poland, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

## Key facts

- **Recall number:** Z-1022-2023
- **Recalling firm:** SynCardia Systems LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-11-02
- **Report date:** 2023-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tucson, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1022-2023

## Citation

> AI Analytics. FDA recall Z-1022-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1022-2023. Source: US FDA. Licensed CC0.

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