Thoratec recalls HeartMate 3 Left Ventricular Assist Systems with potential Extrinsic Outflow Graft Obstruction (EOGO) that may cause device malfunction. Affected units include specific model numbers and serial ranges.
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Thoratec is recalling HeartMate 3 Left Ventricular Assist Systems (LVAS) due to a potential issue called Extrinsic Outflow Graft Obstruction (EOGO) that could cause the device to malfunction. This recall affects specific model numbers and serial ranges of the LVAS.
The hazard involves a deformation of the outflow graft known as Extrinsic Outflow Graft Obstruction (EOGO). This issue has been observed with the HeartMate 3 LVAS and could potentially cause device malfunction, though the exact mechanism of harm is not specified in the recall notice.
Patients with advanced heart failure who use the HeartMate 3 LVAS are most at risk. The recall applies to specific model numbers and serial ranges of the device.
Check if your HeartMate 3 LVAS has a model number of 105581, 105581US, 105581INT, 106524, 106524US, or 106524INT. The serial numbers listed in the recall are specific to these models.
Identify your HeartMate 3 LVAS model number (105581, 105581US, 105581INT, 106524, 106524US, or 106524INT) to determine if it's affected.
Check if your device's serial number matches any of the listed serial numbers for the affected models.
The recall notes an observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with the HeartMate 3 LVAS.
Check if your HeartMate 3 LVAS has a model number of 105581, 105581US, 105581INT, 106524, 106524US, or 106524INT, and if your serial number matches any of the listed serial numbers.
The recall does not specify a remedy, so affected users should contact Thoratec directly for further instructions.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-1301-2024 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-1301-2024 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.
