PureWick PWKIT03HRecalls & reported problems
C. R. Bard, Inc. · PureWick Urine Collection System · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741231537), received between Sep 9, 2026 and Sep 9, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Decrease in Suction” (1 report).
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 Suction1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696503 ↗
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 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.