PureWick Urine Collection System PW200Recalls & reported problems
C. R. Bard, Inc. · PureWick Urine Collection System Kit, Battery · Class 1
All models of PureWick Urine Collection System (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This battery version of the PureWick urine collection system collects urine without an indwelling catheter. Its 456 reports mostly describe suction weakening over time, with some describing overheating and urinary tract infections. The reports include no deaths and 61 injuries. 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
- 501
- Deaths reported
- 0
- Injuries reported
- 61
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 501 adverse event reports that list this exact device (DI 00801741185359), received between Aug 29, 2020 and Sep 30, 2026 — classified as 61 injuries, 440 malfunctions.
The most frequently reported specific device problem is “Decrease in Suction” (347 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
- Decrease in Suction347
- Increase in Suction30
- Overheating of Device30
- Illegible Information23
- Inadequate or Insufficient Training21
- Suction Failure14
- Component Missing10
- Adverse Event Without Identified Device or Use Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions428
- Urinary Tract Infection35
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Skin Inflammation/ Irritation8
- Unspecified Infection8
- Pressure Sore/Ulcer7
- Pain6
- Discomfort5
Recent adverse event reports
The 25 most recent of 501 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952611 ↗MalfunctionSep 29, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941216 ↗MalfunctionSep 28, 2026Increase in Suction
Patient problems: Discomfort
MAUDE report 50924413 ↗MalfunctionSep 28, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924409 ↗MalfunctionSep 28, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917212 ↗MalfunctionSep 28, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916287 ↗MalfunctionSep 25, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903551 ↗MalfunctionSep 25, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903547 ↗MalfunctionSep 25, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899374 ↗MalfunctionSep 25, 2026Decrease in Suction
It was reported that the Customer states that the PW200 was not suctioning at all while conducting water test on tubing. No impact/injury was reported. Male wicksTroubleshooting was performed and the issue was not resolved.Lot/Serial number was not provided
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899359 ↗MalfunctionSep 24, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889824 ↗MalfunctionSep 23, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873294 ↗MalfunctionSep 18, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828916 ↗MalfunctionSep 18, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828911 ↗MalfunctionSep 18, 2026Decrease in Suction
It was reported that the 57PW200 unit not suctioning urine through male wick.Action Taken: tried ts customer was not where the unit was located at the time will call back.Used with female wicks. No additional information provided.It's Unclear if Troubleshooting was provided.(Prepping and placement tips shared).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819871 ↗MalfunctionSep 18, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819865 ↗MalfunctionSep 17, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50808568 ↗MalfunctionSep 15, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781996 ↗MalfunctionSep 15, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781542 ↗MalfunctionSep 14, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765663 ↗MalfunctionSep 14, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765276 ↗MalfunctionSep 11, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734405 ↗MalfunctionSep 10, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722285 ↗MalfunctionSep 10, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718389 ↗MalfunctionSep 10, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50718386 ↗
Other Collector, urine, powered, non indwelling catheter devices
- PureWick Female External Catheter PWFX30C. R. Bard, Inc. · Collector, urine, powered, non indwelling catheter7 deaths1,091 reports
- PureWick Urine Collection System PW100C. R. Bard, Inc. · Collector, urine, powered, non indwelling catheter494 reports
- PureWick PWFXH30C. R. Bard, Inc. · Collector, urine, powered, non indwelling catheter230 reports
- PureWick Urine Collection System PWKIT03C. R. Bard, Inc. · Collector, urine, powered, non indwelling catheter101 reports
- PureWick PWMX30C. R. Bard, Inc. · Collector, urine, powered, non indwelling catheter1 death85 reports
- PureWick Female External Catheter PWF030C. R. Bard, Inc. · Collector, urine, powered, non indwelling catheter66 reports
- DryDoc Vacuum Station DD15C. R. Bard, Inc. · Collector, urine, powered, non indwelling catheter43 reports
- PureWick Female External Catheter PWF030FC. R. Bard, Inc. · Collector, urine, powered, non indwelling catheter17 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.
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