PureWick Female External CatheterRecalls & reported problems across all models

We found 5 models of PureWick Female External Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 1,184 adverse event reports in the FDA's MAUDE database, received between Oct 26, 2017 and Sep 29, 2026 — classified as 7 deaths, 1,027 injuries, 150 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (343 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

Most reported PureWick Female External Catheter problems

PureWick Female External Catheter models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PureWick Female External Catheter PWFX30

  Collector, urine, powered, non indwelling catheter
  7 deaths1,091 reports
• PureWick Female External Catheter PWF030

  Collector, urine, powered, non indwelling catheter
  66 reports
• PureWick Female External Catheter PWF030F

  Collector, urine, powered, non indwelling catheter
  17 reports
• PureWick Female External Catheter PWF030K

  Collector, urine, powered, non indwelling catheter
  9 reports
• PureWick Female External Catheter PWFX30L

  Collector, urine, powered, non indwelling catheter
  1 report

Recent PureWick Female External Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Urinary Tract Infection

  MAUDE report 50940506 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the customer was experiencing leakage from the hose but was able to resolve it with surgical tape. It's unclear if lot number was requested. Used with female wicks. Unclear if medical intervention was provided.No additional information provided. Per customer via phone on (b)(6)m2026, it was reported that it was never confirmed that the device or wicks caused her urinary tract infection (UTI). Customer stated that she thoroughly cleans the device with alcohol to eliminate bacteria. She also stated that her home care nurse verified that the device is suctioning properly. At this time, she is unsure of how she acquired the UTI. She is currently still using the device, and no further issues were reported.

  Patient problems: Urinary Tract Infection

  MAUDE report 50839600 ↗
• InjurySep 10, 2026Patient Device Interaction Problem

  It was reported that the Customer has a UTI and is unable to use wicks while it's active as her doc told her. said they'd call again once it cleared up to make new orders. It's unclear if lot number was requested. Unclear if medical intervention was provided.No additional information provided.

  Patient problems: Urinary Tract Infection

  MAUDE report 50718391 ↗
• MalfunctionAug 27, 2026Decrease in Suction

  It was reported that the customer stated wick is not suctioning but also stated she was trying to reuse wicksUnknown wicks. No additional information provided. It's Unclear if Troubleshooting was provided

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482308 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Auth said after 3 weeks system stopped working and LMS took too long to send a replacement, states because of that patient ended up in the hospital with UTI. It is unclear if the lot number was requested. No additional information provided. Used with female wicks.It was unknown what medical intervention was provided for urinary tract infection.

  Patient problems: Urinary Tract Infection

  MAUDE report 50104951 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Patient said she is getting a UTI from PW and its causing skin irritation. Doctor recommends she no longer uses. It is unclear if the lot number was requested. No additional information provided.

  Patient problems: Skin Inflammation/ Irritation; Urinary Tract Infection

  MAUDE report 50039144 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  (B)(6) SAID MOTHER PASSED AWAY FROM UTI AND BELIEVES IT WAS BECAUSE OF THE PWICKS.\ IT IS UNKNOWN IF TROUBLESHOOTING WAS PERFORMED\ LOT/SERIAL NUMBER WAS NOT PROVIDED IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 25784104 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ASKED FOR THE ORDER TO BE CANCELED. SAID SHE IS GETTING UTI'S WITH IT. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24958748 ↗
• InjuryApr 15, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PT SAID THERE IS LEAKING. SKIN BREAKDOWN DUE TO BEING SOAKING WET. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL 10APR2026, AUTH ADVISED THEY PURCHASED THE UNIT FROM PW CAREWELL AND IT IS WORKING GREAT. PATIENT IS STILL WAKING UP WET BUT CANNISTER IS ALWAYS MORE THAN 1/2 FULL SO THEY BELIEVE THE PW IS CATCHING MOST OF THE URINE. AUTH ADVISED PATIENT DEVELOPED TWO UTIS THAT THEY ARE UNSURE ARE CAUSED BY PW USE. PATIENT HAS HAD NO FURTHER SKIN BREAKDOWN.

  Patient problems: Tissue Breakdown; Urinary Tract Infection

  MAUDE report 24891314 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS NOW GETTING UTIS AND THE CONNECTOR IS DISCONNECTING THE WICK FROM THE TUBING. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED OR LOT NUMBER REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24879602 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  PT SAID THAT THE TUBING IS NOT WORKING BY ITSELF - SHE DOESN'T WANT TO BUY THE WHOLE KIT. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED.\ USED WITH FEMALE WICKS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. PER CUSTOMER VIA EMAIL ON 31MAR2026, IT WAS REPORTED THAT THEIR MOM DID GET A UTI. UNFORTUNATELY, DUE TO THE DEFECTIVE PART ON THE TUBING THE CONNECTOR CAME OFF WITH THE WICK AND GOT ACCIDENTALLY THROWN AWAY. THEY CALLED TO SEE IF WE COULD JUST PURCHASE THE TUBE AND WAS TOLD THEIR MOM WOULD HAVE TO BUY THE WHOLE KIT AGAIN. THE REPRESENTATIVE SAID LAST ONE WE BOUGHT WAS OCTOBER. THAT WAS INCORRECT. THEY PAID FOR A BRAND-NEW MACHINE IN DECEMBER BECAUSE IT DID NOT TURN ON. THEY NEVER HAD THIS PROBLEM WITH THE TUBING AND CONNECTOR IN THE 5 YRS THEY HAVE HAD THIS. THIS STARTED WITH THE NEW MACHINE AND THE KIT FROM BEFORE. NOT SURE IF YOU CHANGED MANUFACTURES. THERE SHOULD BE AWAY TO JUST BUY A NEW TUBE WITHOUT SPENDING 95.00 FOR A WHOLE NEW KIT WHEN THEY WERE NOT READY FOR ONE YET. THEY DID NOT KNOW WHERE TO FIND THE LOT NUMBER. IT WOULD BE FROM THE DECEMBER PURCHASE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24815893 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER STATES THE PW SYSTEM IS WORKING FINE BUT WANTS TO KNOW IF WE HAVE ADDRESSED THE ISSUE WITH THE PW SYSTEM CAUSING BLADDER INFECTIONS. REP EXPLAINED WE HAVE NOT HAD ANY REPORTED ISSUES PERTAINING ANY INFECTIONS. ADVISED SHE CONTACT HER DOCTOR REGARDING THIS, SHE STATES SHE HAS AND IS ON ANTIBIOTICS. ALSO ASKED IF SHE HAS BEEN REPLACING THE WICKS EVERY 8 HOURS AND SHE STATED SHE HAS BEEN DOING SO; NO SUPPLIES HAS BEEN PURCHASED FROM US SINCE 2024 PER ORDER HISTORY. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. NO TROUBLESHOOTING WAS PROVIDED. (PREPPING AND PLACEMENT TIPS SHARED).

  Patient problems: Unspecified Infection

  MAUDE report 24781652 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  PT DAUGHTER REPORTING THAT SHE GOT UTI DUE TO USE OF PW SYSTEM. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. IT IS UNCLEAR IS LOT/SERIAL NUMBER WAS PROVIDED. NO MEDICAL IMPACT/INJURY WAS REPORTED. USED WITH FEMALE WICKS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24758843 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY CUSTOMER THAT THE DEVICE UNITS WERE MOSTLY COVERED BY SHEETS AND CHUX BY BODY POSITIONING, CAUSING VENTS UNABLE TO RECEIVE AIR WHEN USING THE PUREWICK EXTERNAL FEMALE CATHETER. CUSTOMER STATED THAT THIS HAD INCREASED FOLEY CATHETER UTILIZATION AND IN AT LEAST ONE INSTANCE HAD LED TO A CATHETER ASSOCIATED URINARY TRACT INFECTION AFTER MORE THAN A YEAR WITHOUT ONE.IT WAS REPORTED BY CUSTOMER THAT STAFF HAD REPORTED SKIN IRRITATION, REACTIONS FROM MOISTURE, AND CONCERNS ABOUT POTENTIAL DEVICE RELATED PRESSURE INJURIES. CUSTOMER REPORTED THAT NURSES HAD USED MULTIPLE ADDITIONAL SKIN PROTECTIVE PRODUCTS AND MATERIALS TO OFFSET THESE ISSUES AND THAT PATIENTS USING INCONTINENCE PADS SUCH AS CHUX AND OPEN DIAPERS HAD EXPERIENCED INCREASED RISK FOR THE SKIN IN PLACE.

  Patient problems: Urinary Tract Infection

  MAUDE report 24720817 ↗
• InjuryMar 13, 2026Patient Device Interaction Problem

  PATIENT SAID SHE HAS A DECUBITUS ULCER FROM USING PW IN THE HOSPITAL. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 24596314 ↗

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
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports
• PureWick Urine Collection System3 models · 1,096 reports