Thoratec Corp. Recall: Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872
Thoratec Corp. Recall: Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Thoratec Corp.; Product: Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ve
| Recalling firm | Thoratec Corp. |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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, TUR |
| Recall initiated | 20190301 |
| Recall number | Z-1203-2019 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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