PureWick Urine Collection System PW100Recalls & reported problems
C. R. Bard, Inc. · PureWick Urine Collection System Kit, Non-Battery · Class 1
Quick summary
This PureWick urine collection system is a powered device that collects urine from patients without using an indwelling catheter. Its 461 reports mostly describe the suction weakening or stopping, with some reports of overheating and urinary tract infections. There are no deaths and 63 injuries, and reports rose to 174 in the last 12 months from 96 in the 12 months before. 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
- 494
- Deaths reported
- 0
- Injuries reported
- 63
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 494 adverse event reports that list this exact device (DI 00801741185342), received between Jun 12, 2020 and Sep 30, 2026 — classified as 63 injuries, 431 malfunctions.
The most frequently reported specific device problem is “Decrease in Suction” (302 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
- Decrease in Suction302
- Inadequate or Insufficient Training38
- Overheating of Device34
- Increase in Suction33
- Illegible Information26
- Biocompatibility21
- Suction Failure13
- Device Handling Problem12
Patient problems
- No Clinical Signs, Symptoms or Conditions415
- Urinary Tract Infection37
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- Unspecified Infection9
- Pressure Sore/Ulcer8
- Skin Inflammation/ Irritation7
- Pain6
- Bruise/Contusion3
Recent adverse event reports
The 25 most recent of 494 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953975 ↗MalfunctionSep 30, 2026Decrease in Suction
It was reported that the Pure Wick Urine Collection System experience an issue when the suction function was initiated. According to the report, once the system began suctioning, fluid accumulated within the device and subsequently leak, resulting in improper operation and potential containment failure. The customer indicated that the leakage consistently occurred during use when suction starts, preventing the device from functioning as intended.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951851 ↗MalfunctionSep 30, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950579 ↗MalfunctionSep 29, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940866 ↗MalfunctionSep 29, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938992 ↗MalfunctionSep 28, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917206 ↗MalfunctionSep 28, 2026Decrease in Suction
It was reported that the customer contacted Customer Support to report a suspected product malfunction involving the PureWick¿ PW100 Device. The customer stated that the device did not appear to be functioning properly and that multiple attempts were made to use the product without success. According to the customer, the issue appeared to be related to a lack of suction, as the device was not providing the expected performance during use. The customer reported that several troubleshooting attempts were made; however, the problem persisted. Due to the repeated failure of the device to generate or maintain adequate suction, the customer believed the product might be defective. The complaint was documented as a potential product malfunction related to the suction functionality of the PureWick¿ PW100 Device. Further investigation was required to determine the root cause of the reported issue and assess whether the device met product specifications. The lot number was not available at the time of the call.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916275 ↗MalfunctionSep 28, 2026Decrease in Suction
It was reported that the Patient said the unit isn't suctioning and causing the wicks to leak. Did trouble shoot with the unit plugged into the wall, the unit passed the test. Informed the Patient unit should only be used plugged into the wall. It's unclear if lot number was requested. Used with male wicks.No additional information provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916266 ↗MalfunctionSep 25, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899369 ↗MalfunctionSep 24, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889812 ↗MalfunctionSep 23, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873308 ↗MalfunctionSep 22, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858521 ↗MalfunctionSep 21, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848299 ↗MalfunctionSep 18, 2026Decrease in Suction
It was reported that the customer called in to get help, suctioning issues on her system has persisted for about a week.It is unclear if troubleshooting was performed. Lot/Serial number was not provided. No impact/injury was reported. Male wicks
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819873 ↗MalfunctionSep 17, 2026Decrease in Suction
It was reported that the Purewick Urine Collection System was not suctioning properly.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802963 ↗MalfunctionSep 17, 2026Decrease in Suction
It was reported that the Pure Wick Urine Collection System were used with the replacement canister. However, after overnight use, the canister remained empty, and the lack of suction resulted in urine leakage. The customer was transferred to the Medical Information department, where a water suction test was performed (removing the catheter and placing the bare tubing into a cup of water while the machine was running). Despite the motor operating and the power indicator light being on, the device failed to draw any water, confirmed a suction failure.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802960 ↗MalfunctionSep 15, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781543 ↗MalfunctionSep 14, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764429 ↗MalfunctionSep 11, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735895 ↗MalfunctionSep 11, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734408 ↗MalfunctionSep 11, 2026Decrease in Suction
It was reported that the customer states the device did not suction. No Injury Reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734406 ↗MalfunctionSep 11, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50734401 ↗MalfunctionSep 10, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716249 ↗MalfunctionSep 4, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616655 ↗MalfunctionSep 4, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50614420 ↗
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 PW200C. R. Bard, Inc. · Collector, urine, powered, non indwelling catheter501 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.