# FDA recall Z-1301-2024

> **Thoratec Corp.** · Class I · device recall initiated 2024-02-19.

## Product

HeartMate 3 Left Ventricular Assist System (LVAS):  1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE)  2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US  3. HeartMate 3 Sealed Outflow Graft with Bend Relief, OUS  4. HeartMate 3 LVAS Implant Kit, IDE  5. HeartMate 3 LVAS Implant Kit, US  6. HeartMate 3 LVAS Implant Kit, OUS   HeartMate 3 Left Ventricular Assist System:  The HeartMate 3 LVAS is designed to provide therapeutic benefit to those affected with advanced heart failure. The LVAS assumes some or all of the workload of the left ventricle.  The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus supporting equipment.

## Reason for recall

Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.

## Distribution

Worldwide distribution: U.S.(nationwide): AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI,  and WV; and  O.U.S.(foreign) to countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Island, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Libya, Liechtenstein, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and South Korea.

## Key facts

- **Recall number:** Z-1301-2024
- **Recalling firm:** Thoratec Corp.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-19
- **Report date:** 2024-03-27

- **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-1301-2024

## Citation

> AI Analytics. FDA recall Z-1301-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1301-2024. Source: US FDA. Licensed CC0.

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