Thoratec recalls HeartMate 3 LVAS Implant Kit (REF:106524US) due to potential leak path at seal interface. This may cause complications for heart failure patients. Check your serial numbers for affected units.
Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
Thoratec is recalling HeartMate 3 LVAS Implant Kits with specific serial numbers due to a potential leak path at the seal interface between the inflow cannula and titanium apical cuff. This could lead to complications for patients using the device.
The device has a potential leak path at the seal interface where the left ventricle assist system inflow cannula connects to the titanium apical cuff. This leak could allow fluid to escape, potentially causing complications for patients relying on the device for heart support.
Patients with heart failure who have received the HeartMate 3 LVAS Implant Kit with the listed serial numbers are most at risk. The recall affects specific units manufactured under the REF:106524US designation.
Check your HeartMate 3 LVAS Implant Kit for the serial numbers listed in the recall (e.g., MLP-026628, MLP-026733, etc.). The product was sold with a specific reference number (REF:106524US) and sterile packaging.
Compare your device's serial number with the list of affected units provided in the recall notice.
Reach out to Thoratec directly for guidance on next steps if your device is affected.
Check your serial number against the list of affected units provided in the recall notice. The specific serial numbers are listed in the recall documentation.
Contact Thoratec directly for guidance on next steps. They will provide instructions for handling affected units.
Review the list of serial numbers provided in the recall notice. Affected units have specific serial numbers starting with 'MLP-' as listed in the recall documentation.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-1692-2024 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-1692-2024 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.
