THORATEC HEARTMATE GOGEAR, SHOWER BAGRecalls & reported problems across all models

We found 2 models of THORATEC HEARTMATE GOGEAR, SHOWER BAG by Thoratec Corporation in the FDA's device registry (GUDID). Together they are named in 76 adverse event reports in the FDA's MAUDE database, received between Aug 1, 2019 and Aug 27, 2026 — classified as 2 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (71 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported THORATEC HEARTMATE GOGEAR, SHOWER BAG problems

THORATEC HEARTMATE GOGEAR, SHOWER BAG models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG 104232

  Ventricular (Assisst) Bypass
  74 reports
• THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG 104216

  Ventricular (Assisst) Bypass
  2 reports

Recent THORATEC HEARTMATE GOGEAR, SHOWER BAG adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Mechanical Problem

  It was reported that the System Controller was showing a Controller Fault after the patient took a shower and got the Controller wet. The patient was using the Shower Bag and the Green Running Symbol was illuminated. Once the patient arrived at the emergency department (ED), the patient stated that the Controller Fault deteriorated to red alarms to no LED screen. Green running symbol stayed illuminated. Controller exchanged performed in the ED. Changing the Controller, Batteries and Battery Clips resolved the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50483780 ↗
• MalfunctionJan 14, 2026Mechanical Problem

  IT WAS REPORTED THAT A REPLACEMENT WAS REQUESTED FOR AN ITEM UNDER WARRANTY. IT WAS SAID THE CONSOLIDATED BAG WAS FAULTY AND LEAKING. THE CLIPS GOT WET DUE TO THE BAG. A WARRANTY REQUEST WAS REQUESTED FOR THE SHOWER BAG FOR DELIVERY ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24076895 ↗
• MalfunctionJan 6, 2026Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT SHOWER BAG WAS LEAKING. A WARRANTY REPLACEMENT WAS REQUESTED. ADDITIONAL INFORMATION RECEIVED: ON 31DEC2025 FROM THE CLINICIAN NOTED: PATIENT WEIGHT 222 LBS. NO CAUSE OF THE LEAK WAS IDENTIFIED THEY WERE UNSURE IF THE BAG WAS REPLACED AND STATED THE BAG WOULD NOT BE RETURNING FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23980580 ↗
• MalfunctionDec 15, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WATER LEAKED INTO THE SHOWER BAG AND THE SHOWER BAG WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811278 ↗
• MalfunctionNov 25, 2025Mechanical Problem; Mechanical Problem

  IT WAS UNKNOWN IF ANY ADDITIONAL PRODUCT MAY HAVE BEEN EFFECTED BY FLUID INGRESS. IT WAS NOTED THE PATIENT WAS PROVIDED THE PROPER EDUCATION ON HOW TO USE THE SHOWER BAG. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE IMPACT DUE TO THIS EVENT. THE BAG WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648373 ↗
• MalfunctionNov 21, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WATER HAD STARTED TO PENETRATE THE SHOWER BAG FROM THE BOTTOM. THE BAG WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23621913 ↗
• MalfunctionNov 7, 2025Mechanical Problem; Mechanical Problem

  NO ALARMS OCCURRED RELATED TO THE EVENT. THE BAG WAS REPORTEDLY BEING USED APPROPRIATELY. THERE WAS NO CHANGE IN PATIENT CONDITION AND CONTINUED OBSERVATION WAS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501184 ↗
• MalfunctionNov 3, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WATER WAS GETTING INTO THE SHOWER BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23458095 ↗
• MalfunctionOct 27, 2025Mechanical Problem; Mechanical Problem

  THERE WAS NO INDICATION THAT THE BAG WAS IN INAPPROPRIATE USE AT THE TIME, AND NO DAMAGE TO THE SHOWER BAG WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23395921 ↗
• MalfunctionAug 27, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT OVER THE PAST SIX MONTHS, THE PATIENT EXPERIENCED LEAKS IN THE SHOWER BAGS WHEN TAKING A SHOWER. ALL ZIPPERS AND CLASPS WERE SECURED. THE PATIENT WAS POSITIVE THEY WERE DOING EVERYTHING CORRECT WHEN PUTTING THE BAG TOGETHER AND SETTING UP THE EQUIPMENT. THE EQUIPMENT PROCEDURE WAS REVIEWED WITH THE PATIENT TO ENSURE EVERYTHING WAS CORRECT. BATTERIES REQUIRED DRYING AFTER RECENT SHOWERS DUE TO WATER EXPOSURE INSIDE THE SHOWER BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22907502 ↗
• MalfunctionJun 11, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT LOG FILES WERE SENT FOR REVIEW BECAUSE THE PATIENT STATED THAT THE BATTERY(S) GOT WET WHEN GETTING IN THE SHOWER AND THEN HEARD ALARMS WHEN IT HAPPENED. ON THE DEVICE, IT WAS NOTED THAT THERE WAS A LOW VOLTAGE HAZARD INSTEAD OF THE TYPICAL LOW VOLTAGE ADVISORY. THE SITE WANTED FURTHER ASSESSMENT. TECHNICAL SERVICES (TS) REVIEWED THE SUBMITTED LOG FILES AND FOUND THAT THE PATIENT HAD PERSISTENT PULSATILITY INDEX (PI) EVENTS THAT HAD SHORTENED THE DATA CAPTURE TO JUST SEVERAL HOURS. TS WAS UNSURE WHEN THE SHOWER EVENT HAPPENED, BUT IT LOOKED LIKE IT HAD BEEN OVERWRITTEN WITH NEW INCOMING DATA FROM THE PI EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22186504 ↗
• MalfunctionMay 13, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENTS BATTERIES WERE GETTING WET UPON SHOWERING. THE SYSTEM CONTROLLER WAS ALARMING FOR LOW VOLTAGE. WHEN THE PATIENT LOOKED IN THEIR SHOWER BAG, THE PATIENT NOTICED THE BATTERIES WERE WET WITH WATER AT THE BOTTOM OF THE SHOWER BAG. THE SYSTEM CONTROLLER WAS IN THE SYSTEM CONTROLLER HOLDER AND WAS NOT WET. THE PATIENT CONNECTED TO MOBILE POWER UNIT (MPU) POWER AND WAS INSTRUCTED TO USE NEW BATTERY CLIPS AND BATTERIES. THE OLD BATTERIES AND BATTERY CLIPS WERE TAKEN OUT OF USE. NO WATER DAMAGE TO THE SYSTEM CONTROLLER WAS OBSERVED AND THE SYSTEM CONTROLLER PASSED A SELF-TEST. LOG FILE REVIEW DID NOT REVEAL ANY LOW VOLTAGE EVENTS; HOWEVER, THESE EVENTS MAY HAVE BEEN OVERWRITTEN BY NEW INCOMING DATA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010938 ↗
• MalfunctionMay 1, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WATER WAS SUSPECTED TO HAVE ENTERED THE SHOWER BAG THROUGH ITS UPPER COVER. THE SHOWER BAG WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945104 ↗
• MalfunctionApr 23, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SHOWER BAG WAS NOTED WITH WATER INGRESS. NO DAMAGE WAS NOTED ON THE BAG, AND THERE WERE NO ISSUES WITH THE USAGE METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894938 ↗
• MalfunctionFeb 25, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT DROPPED THEIR EQUIPMENT WHILE IN THE SHOWER IN THE SHOWER BAG. IT WAS UNKNOWN IF THE SHOWER BAG APPROPRIATELY CLOSED AT THE TIME OF THE EVENT THE SYSTEM CONTROLLER GOT WET. LOG FILES WERE SUBMITTED FOR REVIEW AND DID NOT CAPTURE ANY CONTROLLER FAULTS SO THERE DID NOT APPEAR TO BE ANY IMMEDIATE ISSUES WITH THE CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463346 ↗

Other Thoratec Corporation products

• Thoratec HeartMate 39 models · 21,215 reports · 8 recalls
• HeartMate7 models · 525 reports · 4 recalls
• THORATEC HEARTMATE, SYSTEM MONITOR2 models · 415 reports · 1 recall
• HeartMate 39 models · 298 reports · 3 recalls
• HeartMate Touch3 models · 63 reports · 1 recall
• CentriMag3 models · 23 reports · 1 recall
• HeartMate II, System Controller2 models · 25 reports