Thoratec recalls HeartMate 3 Coring Tool (REF 10005872) due to small black plastic particles found in left ventricle during implant. Affected units have specific lot numbers.
Small black plastic particle was observed in the left ventricle during implant procedure.
Thoratec is recalling its HeartMate 3 Coring Tool (REF 10005872) because small black plastic particles were observed in the left ventricle during implant procedures. This could pose a risk to patients using the device.
During implant procedures, small black plastic particles were found in the left ventricle. This could potentially cause complications if the particles remain in the heart after implantation.
Patients with the HeartMate 3 Left Ventricular Assist System who use the recalled coring tool. Those with the specific lot numbers listed in the recall are most at risk.
Check if your HeartMate 3 Left Ventricular Assist System has the coring tool with lot numbers: 6675594, 6675724, 6675730, and other numbers listed in the recall. The product is an optional accessory for the HeartMate 3 Left system.
Identify if your HeartMate 3 Coring Tool has one of the listed lot numbers: 6675594, 6675724, 6675730, or other specific numbers provided in the recall.
The recall states small black plastic particles were observed in the left ventricle during implant procedures, but the recall does not specify if the product is dangerous to use in normal conditions.
The recall does not provide a remedy, so the official notice does not specify actions to take.
Check if your HeartMate 3 Coring Tool has a lot number listed in the recall: 6675594, 6675724, 6675730, or other specific numbers provided in the recall.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-1203-2019 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-1203-2019 from Thoratec. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
