# FDA recall Z-1203-2019

> **Thoratec Corp.** · Class II · device recall initiated 2019-03-01.

## Product

Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only,  REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

## Reason for recall

Small black plastic particle was observed in the left ventricle during implant procedure.

## Distribution

US Nationwide distribution in the states of MN, WI, TX, NC, GA, OK, UT, NY, SC, IL, LA, MI, IN, CA, OH, WA.    Foreign (OUS): AUSTRIA, BELGIUM, CANADA, ESTONIA, FRANCE, GERMANY, GREECE, INDIA, ITALY, KUWAIT, LIECHTENSTEIN, LITHUANIA, NETHERLANDS, POLAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TURKEY, UNITED KINGDOM

## Key facts

- **Recall number:** Z-1203-2019
- **Recalling firm:** Thoratec Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-01
- **Report date:** 2019-05-01
- **Termination date:** 2022-08-10

- **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-1203-2019

## Citation

> AI Analytics. FDA recall Z-1203-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1203-2019. Source: US FDA. Licensed CC0.

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