Thoratec recalls Heartmate 3 Sealed Outflow Graft with Bend Relief for potential leaking during implantation. If the C-Ring isn't seated properly, the device may not function during surgery.
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 Sealed Outflow Graft parts that could leak during implantation if the C-Ring isn't properly seated. This could cause the device to malfunction during surgery, putting patients at risk.
The outflow graft can leak at the pump connection if the C-Ring isn't seated correctly during implantation. This leakage can cause the device to become nonfunctional during surgery, potentially leading to complications for the patient.
Patients with left ventricular assist devices (LVADs) who received this specific outflow graft part during implantation. Medical teams performing the surgery are most at risk if the graft leaks.
Check for the part number REF 105581US/105581 on the device. The UDI is 00813024013266 or batch numbers 6613000 and below or 50000000 and higher.
Look for the part number REF 105581US/105581 and UDI 00813024013266 on the device.
The recall states that if the C-Ring is insufficiently seated, the device may leak during implantation and become nonfunctional. This part is not safe for use in surgery without proper seating of the C-Ring.
Check for the part number REF 105581US/105581 and UDI 00813024013266. Batch numbers 6613000 and below or 50000000 and higher are also recalled.
The recall does not specify a remedy, so contact Thoratec directly for guidance on next steps.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-2349-2019 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-2349-2019 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.
