# FDA recall Z-1774-2018

> **Abbott** · Class I · device recall initiated 2018-04-05.

## Product

Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3    Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

## Reason for recall

Reports of outflow graft twist occlusions.  Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.

## Distribution

Worldwide Distribution -- U.S., including the states of MN, PA, IL, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, OH, NY, GA, VA, FL, OK, MD, ME, SC, IN, LA, OR, WA, AL, CO, IA, KS, KY, UT, DC, and CT; and, the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, Cayman Islands, Colombia, Croatia,  Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Kuwait, Lebanon, Malaysia, Montenegro, Netherlands, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia,   Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-1774-2018
- **Recalling firm:** Abbott
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-05
- **Report date:** 2018-05-23
- **Termination date:** 2021-10-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pleasanton, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1774-2018

## Citation

> AI Analytics. FDA recall Z-1774-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1774-2018. Source: US FDA. Licensed CC0.

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