# FDA recall Z-1300-2024

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

## Product

HeartMate II Left Ventricular Assist System (LVAS):  1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393  2. HeartMate II LVAS Implant Kit, US REF 106015  3. HeartMate II LVAS Implant Kit, OUS REF 106016    Update (February 14, 2024)  HeartMate II Left Ventricular Assist System (LVAS):  1. HeartMate II LVAS Implant Kit, OUS REF 102139  2. HeartMate II LVAS Implant Kit, US REF 1355  3. HeartMate II LVAS Implant Kit (with RSOC Controller), US REF 103695  4. HeartMate II LVAS Implant Kit (with RSOC Controller), OUS REF 103693  5. HeartMate II LVAS Implant Kit (with Sealed Graft), US REF 104911  6. HeartMate II LVAS Implant Kit (with Sealed Graft), OUS REF 104912  7. HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) REF 107801  8. HeartMate II LVAS Implant Kit, (EPC), CANADA REF 103695-CAN  9. HeartMate II LVAS Implant Kit (with Sealed Graft), JAPAN REF 104911JPN  10. HeartMate II LVAS Implant Kit (with Pocket System Controller and Sealed Grafts), for geographie

## 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-1300-2024
- **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-1300-2024

## Citation

> AI Analytics. FDA recall Z-1300-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1300-2024. Source: US FDA. Licensed CC0.

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