Thoratec® HeartMate 3™ Tunneling Lance and Handle 106533USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813024013211), received between Jan 7, 2019 and Dec 11, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE SHORT TUNNELING LANCE DID NOT PROPERLY ENGAGE IN THE HANDLE OF THE TUNNELING TOOL. THE LONGER VERSION ENDED UP WORKING BUT IT WAS SAID THEY WANTED TO RETURN THE HANDLE AND SHORTER LANCE FOR REPLACEMENT/REPAIR. THE LONGER LANCE WAS NOT PREFERRED BY SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23780467 ↗
• MalfunctionFeb 3, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT THE 16 INCH TUNNELING SET WAS NOT ENGAGING TO THE HANDLE CORRECTLY AND THAT THERE WAS TOO MUCH TO GIVE WHEN IT WAS PULLED BACK TO CHECK THE CONNECTION. THE HANDLE ON THE 24" TUNNELER WAS USED TO SEE IF THE SAME PROBLEM OCCURRED AND IT WAS DETERMINED THAT IT WAS SOLELY 16 INCH TUNNELING SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16297699 ↗
• InjuryJan 7, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2018. IT WAS REPORTED THAT DURING THE IMPLANT, THE SURGEON TUNNELED THE DRIVELINE, BUT UPON EXITING THE SKIN, 3 PETALS FROM THE TUNNELING BULLET WERE RETAINED. ALL 3 PETALS OF THE TUNNELING BULLET WERE RETRIEVED. REPORTEDLY, THE SURGEON HAD CORRECTLY MOVED THE METAL PORTION TO COVER THE YELLOW LINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8224543 ↗