# FDA recall Z-2348-2019

> **Thoratec Corp.** · Class II · device recall initiated 2019-03-30.

## Product

Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System

## Reason for recall

Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.

## Distribution

Worldwide distribution.  US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania, Switzerland, Thailand, United Kingdom.

## Key facts

- **Recall number:** Z-2348-2019
- **Recalling firm:** Thoratec Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-30
- **Report date:** 2019-08-28
- **Termination date:** 2020-08-24

- **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-2348-2019

## Citation

> AI Analytics. FDA recall Z-2348-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2348-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*