Thoratec® HeartMate 3™ Surgical Hand Tools 10002222USRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813024013259), received between Dec 31, 2021 and Dec 31, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2021Mechanical Problem; Difficult or Delayed Separation; Mechanical Problem; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING IMPLANT THE APICAL CUFF APPEARED TO ATTACHED CORRECTLY. THE YELLOW INDICATOR ON THE CUFF LOCK WAS NOT EXPOSED AND THE PURPLE LEVEL CLOSED WITH EASE. THERE WAS NO APPARENT BLEEDING ON THE HEART. THE TEAM CONTINUED THE IMPLANT PROCEDURE. DURING PREPARATION FOR THE CHEST CLOSURE, IT WAS NOTICED THAT THERE WAS A SIGNIFICANT AMOUNT OF BLEEDING BETWEEN THE CUFF AND THE PUMP. THE PATIENT WAS PUT BACK ON CARDIOPULMONARY BYPASS (CPB) . THE T-CLAMP WAS USED TO UNLATCH THE PUMP. IT WAS NOTED THAT THERE WAS A JELLY-LIKE THROMBUS AROUND THE CUFF AND IN BETWEEN THE CUFF THAT INDICATED SIGNIFICANT BLEEDING AND THAT THE PUMP WAS FREELY ROTATING AROUND THE CUFF. THE PUMP (MLP-028298) WAS DEEMED AN OUT OF BOX FAILURE. THE TEAM CONFIRMED THIS WAS AN OUT OF BOX FAILURE BY TESTING A NEW CUFF WITH THE ORIGINAL PUMP. THE NEW CUFF WAS PLACED ON THE PUMP BUT IT WAS VERY DIFFICULT TO REMOVE AND THE T-CLAMP BROKE. A NEW IMPLANT KIT WAS OPENED AND THE PUMP (MLP-025779) WAS USED ALONG WITH THE ORIGINAL APICAL CUFF. THE PATIENT RETURNED TO THE OPERATING ROOM (OR) ON (B)(6) 2021 AND (B)(6) 2021 DUE TO TAMPONADE. RELATED MANUFACTURER REPORT NUMBER FOR ORIGINAL PUMP: 2916596-2021-07329.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13124362 ↗