THORATEC® HEARTMATE II®, PUMP AND CONTROLLER ONLY KIT 105903Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813024011217), received between Jun 26, 2019 and Jan 25, 2023 — classified as 2 deaths, 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

• DeathJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2018. THE CAUSE OF DEATH WAS UNKNOWN AS THE PATIENT WAS FOUND DECEASED IN BED, AND AN AUTOPSY WAS NOT PERFORMED. THE PUMP REPORTEDLY FUNCTIONED AS INTENDED AND THE PATIENT'S OUTCOME WAS NOT SUSPECTED TO BE DEVICE RELATED.

  Patient problems: Insufficient Information

  MAUDE report 16243833 ↗
• DeathApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 13976179 ↗
• InjuryJun 26, 2019Naturally Worn; Material Split, Cut or Torn; Naturally Worn; Material Split, Cut or Torn

  THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2013. IT WAS REPORTED THE PATIENT WAS SEEN FOR A FOLLOW VISIT AND NOTED TO HAVE TWISTING OF DRIVELINE (DL) WITH MULTIPLE PORTIONS COVERED WITH RESCUE TAPE. INTERROGATED DUE TO CONCERN OF INTEGRITY OF WIRES INSIDE DRIVELINE. ON INTERROGATION OF DEVICE, PATIENT HAD NO EXTERNAL POWER ALARM ON (B)(6) THAT OCCURRED WHEN SWITCHING WHITE LEAD ON PATIENT CABLE. THE LOG FILE WAS REVIEWED. THE LOG FILE ANALYSIS SHOWED THE NO EXTERNAL POWER ON (B)(6) 2019 WHILE THE PATIENT WAS SWITCHING POWER SOURCES. THE DL DATA APPEARED NORMAL SO THE TWISTING HAD NOT DEGRADED THE CONDUCTORS AT THIS TIME. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE. THE MCS EQUIPMENT WAS OPERATING AS INTENDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8735884 ↗