Thoratec recalls Heartmate 3 LVAS Implant Kit and Heartmate XVE/II Apical Coring Knives due to inadequate sharpness causing extended surgery time. Affected units have specific serial numbers.
Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.
Thoratec is recalling Heartmate 3 LVAS Implant Kits and Apical Coring Knives because the knives may not be sharp enough to start or complete the coring procedure. This could lead to longer surgery times as the surgeon needs to get a backup knife.
The Apical Coring Knife provided with the Left Ventricular Assist System may not be sharp enough to start or complete the coring procedure. This could cause the surgery to take longer while the surgeon tries to get a backup knife.
Heart transplant patients and their surgical teams who use the Heartmate 3 LVAS Implant Kit or Heartmate XVE/II Apical Coring Knife. Patients with the specific serial numbers listed in the recall are most at risk.
Check if your Heartmate 3 LVAS Implant Kit has serial numbers starting with MLP-034137 to MLP-037708 or MLP-038104 to MLP-039999. The Apical Coring Knife has serial numbers from 132849 to 135062.
Verify your Heartmate 3 LVAS Implant Kit or Apical Coring Knife has the specific serial numbers listed in the recall notice.
The Apical Coring Knife may not be sharp enough to start or complete the coring procedure, which could lead to extended surgery time while the surgeon acquires a backup knife.
Check your serial numbers against the list provided in the recall notice. If you have the affected serial numbers, contact Thoratec for further instructions.
The recall notice does not specify a fix or remedy. Affected users should check their serial numbers and contact Thoratec for guidance.
We’ve drafted a message you can send Thoratec to request your refund or repair — edit it as you like.
Subject: Recall Z-2658-2023 — Thoratec Thoratec Hello, I own a Thoratec that is covered by recall Z-2658-2023 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.
