HeartMate™ GoGear™ 104232Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05415067038173), received between Dec 2, 2025 and Jan 28, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 reports).

18 other recalls cover devices cleared under the same FDA submission (P160054); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Mechanical Problem

  IT WAS REPORTED THAT THE SHOWER BAGS WERE GETTING WATER INTO THEM AT USE. THEY WERE FAULTY AND NOT WORKING PROPERLY. REPLACEMENT WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202103 ↗
• MalfunctionJan 22, 2026Mechanical Problem

  IT WAS REPORTED THAT THE SHOWER BAGS WERE GETTING WATER INTO THEM AT USE. THEY WERE FAULTY AND NOT WORKING PROPERLY. REPLACEMENT WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152412 ↗
• MalfunctionJan 19, 2026Mechanical Problem

  IT WAS REPORTED THAT WATER WAS LEAKING INTO THE PATIENT'S SHOWER BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111489 ↗
• MalfunctionJan 13, 2026Mechanical Problem

  IT WAS REPORTED THAT WATER SEEPED INTO THE SHOWER BAG FROM THE BOTTOM. EVEN WHEN IT WAS COVERED WITH GAUZE, WATER STILL SEEPED IN. THERE WAS NO HEALTH HAZARD TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052237 ↗
• MalfunctionDec 11, 2025Mechanical Problem; Mechanical Problem

  NO OTHER PRODUCTS WERE DAMAGED AS A RESULT OF THE WATER ENTERING THE SHOWER BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782951 ↗
• MalfunctionDec 2, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT'S SHOWER BAG WAS LEAKING. IT WAS LATER REPORTED THAT LEAK WAS DISCOVERED WHILE THE PATIENT WAS SHOWERING AND THAT THE COMPARTMENT WHERE THE BATTERIES ARE PACKED HAD MOISTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697570 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160054. One submission often covers many models, so check the product and lot details in each record.

• Z-2519-2026 · May 13, 2026 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts
• Z-2520-2026 · May 13, 2026 · Open, Classified
  Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Stan
• Z-2518-2026 · May 13, 2026 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left
• Z-0506-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531
• Z-0505-2026 · Oct 9, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS
• Z-2290-2025 · Jun 23, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assis
• Z-2291-2025 · Jun 23, 2025 · Open, Classified
  Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS)
• Z-1570-2025 · Mar 13, 2025 · Open, Classified
  HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
• Z-2583-2024 · Jun 25, 2024 · Open, Classified
  HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Ki
• Z-1921-2024 · May 8, 2024 · Open, Classified
  Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
• Z-1693-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
• Z-1692-2024 · Mar 1, 2024 · Open, Classified
  Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
• Z-1301-2024 · Feb 19, 2024 · Open, Classified
  HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graf
• Z-0842-2024 · Jan 3, 2024 · Open, Classified
  1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate T
• Z-0746-2020 · Dec 2, 2019 · Terminated
  HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, R

…and 3 more.