Thoratec recalls HeartMate 3 LVAS Implant Kit (REF:106524INT) due to potential leak path at seal interface between inflow cannula and titanium apical cuff. This may cause complications for patients with heart failure.
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 because they may have a 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 may develop a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. This could potentially lead to complications for patients using the device.
Patients with heart failure who have received the HeartMate 3 LVAS Implant Kit with the listed serial numbers are affected. Those with the specific model and serial numbers are at risk.
Check your HeartMate 3 LVAS Implant Kit for the serial numbers listed in the recall notice. The specific serial numbers are provided in the recall record.
Verify if your HeartMate 3 LVAS Implant Kit has one of the listed serial numbers.
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.
Check your HeartMate 3 LVAS Implant Kit for the serial numbers listed in the recall notice. The specific serial numbers are provided in the recall record.
The recall record does not specify a remedy, so 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-1693-2024 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-1693-2024 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.
