THORATEC® HEARTMATE® GOGEAR®, SHOWER BAG 104232Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00813024011149), received between Aug 1, 2019 and Aug 27, 2026 — classified as 2 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (69 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 25 most recent of 74 reports, 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 ↗
• MalfunctionFeb 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT INUNDATION WAS NOTED FROM THE LOWER PART OF THE SHOWER BAG. WATER WAS LEAKING FROM THE BOTTOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402508 ↗
• MalfunctionJan 28, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WHEN STARTED USING A SHOWER BAG, WATER HAD ENTERED THE BAG, SO IT WAS REPLACED. THERE WAS NO FLUID INGRESS/DAMAGE OF ANY COMPONENTS CONTAINED IN THE SHOWER BAG. THE BAG WAS USED PROPERLY DURING BATHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21255973 ↗
• MalfunctionJan 14, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SHOWER BAG HAD BEEN USED AS USUAL, BUT WATER HAD PENETRATED THE BAG, SO IT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152413 ↗
• MalfunctionJan 13, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A SUSPECTED LEAKAGE OF THE SHOWER BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143617 ↗
• MalfunctionDec 12, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S SHOWER BAG FILLED WITH WATER WHILE THEY WERE SHOWERING, DESPITE THE CUSTOMER REPORTING THAT THE SHOWER BAG HAD BEEN USED CORRECTLY BY THE PATIENT. THE SYSTEM CONTROLLER WAS WET BUT RECEIVED THE LEAST AMOUNT OF WATER DUE TO BEING AT THE TOP OF THE SHOWER BAG. THE BATTERIES AND BATTERY CLIPS AT THE BOTTOM OF THE SHOWER BAG WERE SUBMERGED IN WATER. MULTIPLE AUDIBLE ALARMS WERE HEARD BY THE PATIENT, WHICH RESOLVED AFTER THEY DRIED THE EQUIPMENT, BUT NO ALARMS WERE FOUND DURING THEIR CLINIC VISIT, AND NO FURTHER ALARMS WERE HEARD. THE PATIENT WAS ASYMPTOMATIC THROUGHOUT THE ENTIRE EVENT, AND NO CHANGES WERE MADE TO THE CONTROLLER. THERE WAS NO DAMAGE TO ANY OF THE EQUIPMENT. EVENT LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED ROUTINE EVENTS DESPITE THE WATER EXPOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919264 ↗
• MalfunctionNov 19, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT WHILE ADMITTED, THE PATIENTS BATTERY CLIP GOT SOAKED IN WATER WHILE THEY WERE SHOWERING. TWO BATTERY CLIPS WERE TO BE RETURNED. THE SITE REPORTED THAT THE PRODUCTS HAD BEEN USED FOLLOWING THE MANUAL. THE CONTROLLER DID NOT GET WET. THE BATTERY HAD GOTTEN A LITTLE BIT WET; THE PRODUCT WAS USED AFTER IT WAS WIPED AND DRIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20729008 ↗
• MalfunctionNov 6, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR EVALUATION CONCERNING LOW VOLTAGE EVENTS ON 12OCT2024. THE LOW BATTERY HAZARD EVENTS THAT OCCURRED APPEARED TO HAVE OCCURRED WHILE ON BATTERY POWER. THE RELATIVE STATE OF CHARGE (RSOC) VALUES RECORDED DURING THE EVENTS WERE UNUSUAL. THE DATA APPEARED TO INDICATE THAT THE PATIENT SWITCHED TO ANOTHER PAIR OF BATTERIES SHORTLY AFTER THESE EVENTS. ADDITIONAL INFORMATION WAS PROVIDED THAT PATIENT DID RECALL THAT THAT THE SHOWER BAG FAILED TO KEEP OUT WATER ON COUPLE OF OCCASIONS. THE PATIENT WAS ADVISED TO TAKE IT OUT OF USE AND WOULD ONLY DO SPONGE BATHS MOVING FORWARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616235 ↗
• MalfunctionSep 22, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE 14 V BATTERIES AND BATTERY CLIPS WERE SUBMERGED WHILE THE PATIENT WAS SHOWERING IN THE HOSPITAL. THERE WERE NO ALARMS AND NO PATIENT CONSEQUENCES. IT WAS COMMUNICATED ON (B)(6) 2024 THAT A SHOWER BAG WAS IN USE AND WAS USED APPROPRIATELY. THE SYSTEM CONTROLLER REMAINED IN USE AS IT DID NOT GET WET. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20276168 ↗
• MalfunctionJul 9, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT PATIENT STATED THEIR SHOWER BAG HAD WATER INTRUSION WHEN THEY WERE BATHING AND THEIR VENTRICULAR ASSIST DEVICE (VAD) ALARMED STATING LOW BATTERY EVEN THOUGH THEY HAD NEW BATTERIES ON. THERE WERE NO OTHER ALARMS OR ISSUES SINCE. NO EQUIPMENT HAD BEEN REPLACED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706078 ↗
• MalfunctionMar 27, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED A YELLOW WRENCH ALARM WHILE SHOWERING. THIS ALARM WAS NOT SEEN UPON INTERROGATION WHEN SEEN IN THE CLINIC. THE PATIENT STATES THE SYSTEM CONTROLLER WAS EXPOSED TO "SOME WATER" DURING SHOWERING EVEN THOUGH THEY WERE USING THE APPROPRIATE SHOWER BAG. THE PATIENT CONFIRMED THAT THE CONTROLLER WAS NOT SUBMERGED IN WATER, STATING THE CONTROLLER "GOT WET BUT WAS NOT SOAKED IN WATER." THE PATIENT REPORTED NO SYMPTOMS DURING THE ALARM AND THAT IT RESOLVED BRIEFLY WITHIN 5-10 SECONDS. LOG FILES WERE SUBMITTED FOR REVIEW AND CAPTURED SOME LOW POWER ADVISORIES DUE TO ROUTINE BATTERY DEPLETION. OTHERWISE, THE LOG FILES CAPTURED ROUTINE EVENTS. THERE WERE NO ADVERSE ALARM CONDITIONS OR PARAMETER CHANGES. RELATED MANUFACTURER'S REFERENCE NUMBER FOR SYSTEM CONTROLLER: 2916596-2024-01550.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988300 ↗