PureWickRecalls & reported problems across all models
C. R. Bard, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 342
- Deaths reported
- 1
- Injuries reported
- 259
- Recalls
- 0
We found 6 models of PureWick by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 342 adverse event reports in the FDA's MAUDE database, received between Nov 5, 2024 and Sep 30, 2026 — classified as 1 death, 259 injuries, 82 malfunctions.
The most frequently reported specific device problem is “Decrease in Suction” (79 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PureWick problems
Device problems
- Adverse Event Without Identified Device or Use Problem169
- Decrease in Suction79
- Patient Device Interaction Problem41
- Fluid/Blood Leak23
- Increase in Suction11
- Use of Device Problem8
- Biocompatibility7
- Device Dislodged or Dislocated4
Patient problems
- Urinary Tract Infection171
- No Clinical Signs, Symptoms or Conditions68
- Skin Inflammation/ Irritation31
- Unspecified Infection23
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available20
- Fungal Infection12
- Pain11
- Skin Discoloration10
PureWick models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PureWick PWFXH30Collector, urine, powered, non indwelling catheter230 reports
- PureWick PWMX30Collector, urine, powered, non indwelling catheter1 death85 reports
- PureWick PW300Collector, urine, powered, non indwelling catheter14 reports
- PureWick PWF030KXCollector, urine, powered, non indwelling catheter11 reports
- PureWick PWF030FXCollector, urine, powered, non indwelling catheter1 report
- PureWick PWKIT03HCollector, urine, powered, non indwelling catheter1 report
Recent PureWick adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Decrease in Suction
Patient problems: Urinary Tract Infection
MAUDE report 50952615 ↗MalfunctionSep 30, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952614 ↗MalfunctionSep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Urinary Tract Infection
MAUDE report 50952613 ↗MalfunctionSep 29, 2026Increase in Suction
Patient problems: Pain
MAUDE report 50940869 ↗MalfunctionSep 29, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940507 ↗InjurySep 28, 2026Patient Device Interaction Problem
Patient problems: Insufficient Information
MAUDE report 50924416 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Urinary Tract Infection
MAUDE report 50923642 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the PT said that got infection last (b)(6), and that she didn't see any literature regarding the cleaning of the canister and tubing. Informed her that cleaning should be with dishwashing detergent and isopropyl alcohol 70% also informed her that we will take note regarding her concern about instructions in cleaning kits. It's unclear if lot number was requested.Unclear if medical intervention was provided.No additional information provided.
Patient problems: Unspecified Infection
MAUDE report 50917204 ↗InjurySep 28, 2026Biocompatibility
It was reported that the customer is having an allergic reaction to the flex wicks. States she believes it may be from the dye or coloring of the wicks but isn't entirely sure. She has brought this up to her provider and requested for them to contact the distributor on her behalf and advocate for her. Apologized and explained that via insurance, only the flex wicks are covered, and patient would have to purchase the original blue wicks out of pocket if she preferred them. She asked if there is any documentation of her doctor calling the distributor. Advised not in relation to her reaction. Again, offered to exchange the wicks for a new box but patient claimed that she received an order of flex wicks twice and has had a reaction. So, she is not interested in another box, nor does she believe this is a one-off scenario. She prefers the original wicks, states she never had this issue with them. It's unclear if lot number was requested. Unclear if medical intervention was provided. No additional information provided. Patient states she will call her doctor.Per customer via email on (b)(6) 2026, it was reported that she has been buying female blue catheters for years with no problems. I
Patient problems: Hypersensitivity/Allergic reaction; Skin Discoloration; Skin Inflammation/ Irritation
MAUDE report 50916293 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Spouse of the Patient states his wife got a UTI from PW. Unclear if medical intervention was provided. It's unclear if lot number was requested. No additional information provided.
Patient problems: Urinary Tract Infection
MAUDE report 50916263 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Insufficient Information; Urinary Tract Infection
MAUDE report 50903530 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the PT said the last time she used it the wicks caused her an infection so she's wanting to cancel the order and won't be using. It was unknown what medical intervention was provided. No additional information provided. It's unclear if lot number was requested.
Patient problems: Unspecified Infection
MAUDE report 50899368 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Urinary Tract Infection
MAUDE report 50889831 ↗InjurySep 24, 2026Patient Device Interaction Problem
Patient problems: Urinary Tract Infection
MAUDE report 50889810 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Urinary Tract Infection
MAUDE report 50809428 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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