THORATEC® HEARTMATE® GOGEAR®, CONSOLIDATED BAG, LEFT 106449Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813024011279), received between Sep 18, 2024 and Sep 3, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 reports).

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.

• MalfunctionSep 3, 2025Mechanical Problem; Mechanical Problem

  IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAD ONLY MICRO BLEEDINGS DUE TO SMALL SKIN LESIONS AROUND THE EXIT SITE WHICH WERE DUE TO THE TENSION OF THE DRIVELINE DURING THE FALL OF THE BAG. THE PATIENT WAS TREATED WITH CLOTTING DRESSINGS, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22960135 ↗
• MalfunctionDec 3, 2024Material Split, Cut or Torn; Device Fell; Material Split, Cut or Torn; Device Fell

  ADDITIONAL INFORMATION PROVIDED THAT DME SENT A REPLACED BAG. THE PATIENT HAD NOT RETURNED THE BAG AND WAS SEEN IN CLINIC ON(B)(6) WITH NO ISSUES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20837879 ↗
• MalfunctionSep 18, 2024Mechanical Problem; Material Split, Cut or Torn; Mechanical Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT'S CARRYING BAG CAME LOOSE AT THE CONNECTION POINT BETWEEN THE CARABINEER RAKE AND THE EYELET, THROUGH WHICH THE CARABINEER RAKE WAS ATTACHED TO THE CARRYING STRAP, AND THE METAL HOCK LOCK OF THE BAG SLOPPED OUT. LOOSENING IT CAUSED THE BAG WITH THE HEARTMATE (HM ) 3 DEVICE TO FALL DOWN. THIS CREATED A STRONG PULL AND TENSION ON THE DRIVELINE, WHICH IN TURN LED TO INJURY OF THE SKIN AND BLEEDING AROUND THE DRIVELINE EXIT SITE. OFTEN A DRIVELINE INFECTION IS DETECTED AT SUCH EVENTS THROUGH MANIPULATION. IN THIS CASE, IT IS STILL TOO EARLY TO MAKE SUCH A STATEMENT, BUT THE PATIENT WAS HARMED. THE CUSTOMER WAS CONCERNED THAT THE PATIENTS MAY NOT FEEL SAFE WEARING THEIR VENTRICULAR ASSIST DEVICES (VADS). PHOTOS OF THE DEFECTIVE CONSOLIDATED BAG WERE REPORTED TO BE AVAILABLE. THE BAG WITH THE REPORTED ISSUE WAS EXCHANGED. THE PATIENT DID THEN DEVELOP A DRIVELINE INFECTION. THEY WERE READMITTED AND TREATED WITH ANTIBIOTICS. THE DRIVELINE EXIT SITE WAS CLEANED AND THE WOUND DRESSING WAS EXCHANGED EVERYDAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20249895 ↗