THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG 104216Recalls & reported problems
Thoratec Corporation · Class 3
All models of THORATEC HEARTMATE GOGEAR, SHOWER BAG (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00813024010456), received between Apr 6, 2022 and Oct 6, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 6, 2023Mechanical Problem; Mechanical Problem
RELATED MFR # 2916596-2023-06965, MFR # 2916596-2023-06966, MFR # 2916596-2023-07006, MFR # 2916596-2023-06967, AND MFR #2916596-2023-06968. IT WAS REPORTED THAT THE PATIENT PERFORMED A CONTROLLER EXCHANGE FOR RED HEART ALARMS AFTER TAKING A SHOWER. THE PATIENT CLAIMED THAT THEIR CONTROLLER AND BATTERY CLIPS HAD FLUID INGRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17888891 ↗MalfunctionApr 6, 2022Mechanical Problem; Mechanical Problem
THE EVENT DATE HAS BEEN ESTIMATED. IT WAS REPORTED THROUGH HISTORICAL REVIEW OF (B)(6) COMPLAINTS THAT THERE WERE SIX INSTANCES OF WATER INFILTRATING THE GOGEAR SHOWER BAG WITHIN ONE YEAR OF INITIAL USE. THESE SHOWER BAGS WERE REPLACED DUE TO THE WATER LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14021995 ↗
Other Ventricular (Assisst) Bypass devices
- Thoratec® HeartMate 3™ 106524USThoratec Corporation · Ventricular (Assisst) Bypass7 recalls5,096 deaths16,478 reports
- THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS) 106015Thoratec Corporation · Ventricular (Assisst) Bypass2 recalls2,141 deaths8,000 reports
- Thoratec® HeartMate 3™ 106531USThoratec Corporation · Ventricular (Assisst) Bypass1 recall11 deaths4,646 reports
- HVAD Pump Implant Kit 1103Heartware Inc. · Ventricular (Assist) Bypass6 recalls424 deaths2,952 reports
- HVAD® Pump Implant Kit (Enhanced) 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls573 deaths2,807 reports
- HVAD® Pump Implant Kit 1103Heartware Inc. · Ventricular (Assisst) Bypass4 recalls666 deaths2,737 reports
- HVAD® Controller 1420Heartware Inc. · Ventricular (Assisst) Bypass5 recalls14 deaths2,161 reports
- HEARTMATE®, MOBILE POWER UNIT, NA 107754Thoratec Corporation · Ventricular (Assisst) Bypass1 death2,098 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page