Thoratec recalls HeartMate II Left Ventricular Assist Systems with Extrinsic Outflow Graft Obstruction (EOGO) risk. Affected units include specific model numbers and serials. Stop using immediately if you have the recalled devices.
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Thoratec is recalling HeartMate II Left Ventricular Assist Systems (LVAS) due to a risk of outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO). This can cause the device to malfunction and potentially lead to serious complications. Affected units have specific model numbers and serials listed in the recall.
The outflow graft can deform under normal use, leading to blockage of blood flow. This may cause the device to malfunction, potentially resulting in serious complications like reduced blood flow or device failure.
Patients with HeartMate II LVAS implants or those who have received the recalled devices. The risk is highest for individuals with the specific model numbers and serials listed in the recall.
Check for model numbers: 103393, 106015 (US), 106016 (OUS), or serial numbers starting with VAD- (e.g., VAD-0357). The recall includes specific model numbers and serials listed in the official notice.
If you have a HeartMate II LVAS with the recalled model numbers or serials, stop using the device right away.
The HeartMate II LVAS is a left ventricular assist system that helps pump blood from the weakened left ventricle to the aorta. It's used for patients with heart failure who need temporary support.
Check the model number on your device or the serial number (which starts with VAD-). The recall includes specific model numbers like 103393 and serials such as VAD-0357.
Yes, if you have the recalled device, contact your doctor immediately to discuss next steps and potential medical care.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-1300-2024 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-1300-2024 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.
