Thoratec recalls HeartMate 3 LVAS Implant Kits with specific batch numbers due to potential outflow graft leaks during implantation if the C-Ring isn't properly seated.
Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.
Thoratec is recalling HeartMate 3 LVAS Implant Kits that could leak during implantation if the C-Ring isn't seated correctly. This risk could cause the device to become nonfunctional during surgery.
If the C-Ring isn't seated properly during implantation, the outflow graft connection can leak. This leak makes the device nonfunctional during the surgery, potentially causing complications.
Patients receiving heart surgery with this specific implant kit are affected. Medical teams using the kit during implant procedures are most at risk.
Check for batch/lot numbers 6613000 or 50000000 or higher on the kit. The kit has a shelf life of 36 months from manufacture date.
Verify the batch/lot number on the kit label to confirm if it's affected (6613000 or 50000000 or higher).
This recall affects patients receiving heart surgery with this specific implant kit and medical teams using the kit during implant procedures.
Batch/lot numbers 6613000 or 50000000 or higher are affected.
The kit has a shelf life of 36 months from the date of manufacture.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-2348-2019 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-2348-2019 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.
