Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1203-2019 — 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 m

U.S. FDA — Device Enforcement · United States · 2019-03-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1203-2019
Date of alert: 2019-03-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Thoratec Corp.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10005872

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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