HeartWare® Shower Bag 2000USRecalls & reported problems
Heartware Inc. · Class 3
Quick summary
The HeartWare Shower Bag 2000US is a bag used to hold and protect the external power unit for a HeartWare ventricular assist device while the patient showers. The 32 reports mostly describe the bag breaking, tearing, splitting at the seams, or leaking, including holes that let water in and a broken shoulder strap clasp; bags were typically replaced. No deaths and no injuries are reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00888707000031), received between Dec 18, 2017 and Sep 11, 2025 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Break” (26 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break26
- Fluid/Blood Leak4
- Material Split, Cut or Torn4
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient24
- No Clinical Signs, Symptoms or Conditions7
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE SHOWER BAG WAS FOUND TO BE TORN. THE SITE INDICATED THAT THE BAG WAS DAMAGED BUT DID NOT SPECIFY THE LOCATION OR CAUSE OF THE TEAR. THE PRODUCT WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23031229 ↗MalfunctionJun 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE SHOWER BAG HAD A HOLE THAT ALLOWED WATER TO LEAK INTO THE SHOWER BAG. THE SHOWER BAG WAS REMOVED FROM SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17070179 ↗MalfunctionMay 30, 2023Break; Break
IT WAS REPORTED THAT THE SHOWER BAG EXHIBITED UNSPECIFIED DAMAGE. THE SHOWER BAG WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17020787 ↗MalfunctionDec 7, 2022Break; Break
IT WAS REPORTED THAT THE SHOWER BAG WAS BROKEN. THE SHOWER BAG WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15932940 ↗MalfunctionOct 10, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE SHOWER BAG WAS WORN AND HAD SOME LEAKING. THE SHOWER BAG WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15573987 ↗MalfunctionJun 28, 2021Break; Break
IT WAS REPORTED THAT THE SHOWER BAG HAD A HOLE. THE SHOWER BAG WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12075656 ↗MalfunctionOct 14, 2020Break; Break
IT WAS REPORTED THAT THE CLASP THAT ATTACHES THE SHOULDER STRAP TO THE SHOWER PACK BAG WAS BROKEN. THE SHOWER PACK WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 10677954 ↗MalfunctionJul 29, 2020Break; Break
IT WAS REPORTED THAT THE SHOWER BAG WAS COMING APART AT THE SEAMS. THE SHOWER BAG WAS REMOVED FROM USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10339748 ↗MalfunctionMay 30, 2019Break; Break
IT WAS REPORTED THAT THE CLIP ON THE PATIENT'S SHOWER BAG BROKE DURING THE FIRST USE AT THE HOSPITAL. THE SHOWER BAG WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8655916 ↗MalfunctionMay 6, 2019Break; Break
IT WAS REPORTED THAT THE BOTTOM OF THE SHOWER BAG WAS RIPPED INTERNALLY. THE SHOWER BAG WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8581868 ↗MalfunctionApr 10, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE SHOWER BAG WAS RIPPED. THE SHOWER BAG WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8499929 ↗MalfunctionApr 9, 2019Break; Break
IT WAS REPORTED THAT THE SHOWER BAG HAD A BROKEN CLIP. THE BAG WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8496756 ↗MalfunctionMar 11, 2019Break; Break
IT WAS REPORTED THAT THE CLIP ATTACHING THE STRAP TO THE SHOWER BAG WAS BROKEN. THE BAG WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8408547 ↗MalfunctionFeb 21, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WATER WAS COLLECTING IN THE BOTTOM OF THE SHOWER BAG WHEN THE PATIENT SHOWERED. THE SHOWER BAG WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8359103 ↗MalfunctionJan 7, 2019Break; Break
IT WAS REPORTED THAT THE CLIP HOLDING THE SHOWER BAG STRAP BROKE WHEN THE STRAP WAS ADJUSTED. THE SHOWER BAG WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8224147 ↗MalfunctionNov 14, 2018Break; Break
IT WAS REPORTED THAT ONE OF THE CLIPS BROKE ON THE SHOWER BAG; NO COMPONENTS FELL OUT OF THE SHOWER BAG. THE SHOWER BAG WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8071334 ↗MalfunctionSep 24, 2018Break; Break
IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) SHOWER BAG WAS DAMAGED. THE BAG WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7903211 ↗MalfunctionSep 24, 2018Break; Break
IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) SHOWER BAG RIPPED. THE BAG WAS EXPECTED TO BE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7901434 ↗MalfunctionSep 21, 2018Break; Break
IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) SHOWER BAG HAD A TEAR ALONG THE SHOULDER STRAP. THE BAG WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7898358 ↗MalfunctionAug 30, 2018Break; Break
IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) SHOWER BAG STRAP WAS TORN. THE SHOWER BAG WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7832324 ↗MalfunctionAug 27, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT'S SHOWER BAG HAD A DAMAGED STRAP. THE SHOWER BAG WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7820429 ↗MalfunctionAug 8, 2018Material Split, Cut or Torn
IT WAS REPORTED THAT THE STRAP TORE OFF OF THE SHOWER BAG. THE SHOWER BAG WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7764729 ↗MalfunctionAug 7, 2018Break; Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak
IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) SHOWER BAG ZIPPER WAS BROKEN AND LEAKING. THE BAG WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7759921 ↗MalfunctionJul 27, 2018Break; Material Split, Cut or Torn; Break
IT WAS REPORTED THAT THE SHOWER BAG HAD A TEAR. THE BAG WAS EXCHANGED. THE BAG WAS RETURNED TO THE MANUFACTURER AND THE DAMAGE WAS DETERMINED TO BE A TORN SHOULDER STRAP. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7727348 ↗MalfunctionJun 20, 2018Break; Break
IT WAS REPORTED THAT THE SHOWER BAG HAD A BROKEN CLIP. THE SHOWER BAG WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7620778 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.