PureWick Female External Catheter PWFX30Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,091 adverse event reports that list this exact device (DI 00801741189050), received between Apr 9, 2020 and Sep 29, 2026 — classified as 7 deaths, 957 injuries, 127 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (330 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,091 reports, 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 ↗
• InjuryMar 13, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE AUTH ADVISED SOMETIMES THERE IS LEAKING AND SOMETIMES THEY GO A FEW WEEKS WITH NO LEAKING. PATIENT HAS TO LIE ON SIDE DUE TO BED SORES. NURSE ADVISED ON TIPS. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 24595853 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION. CALLER STATES HER MOTHER IS RECEIVING UTIS FROM THE SYSTEM. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN IF LOT/SERIAL NUMBER WAS REQUESTED. USED WITH FEMALE WICKS.

  Patient problems: Urinary Tract Infection

  MAUDE report 24594582 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  CUSTOMER STATES THAT SHE GOT UTI FROM WICKS SHE ORDERED FROM AMAZON. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN IF LOT/SERIAL NUMBER WAS REQUESTED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24565048 ↗
• InjuryFeb 27, 2026Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS STAYING WET AND GETTING UTI'S. AS CANCELED ADVISED KIT IS SUPPOSED TO BE REPLACED EVERY 60 DAYS. NO ADDITIONAL INFORMATION PROVIDED. NO TROUBLESHOOTING WAS PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION. (PREPPING AND PLACEMENT TIPS SHARED).

  Patient problems: Urinary Tract Infection

  MAUDE report 24475404 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SAID THE WICKS CAUSE INFECTIONS AND RASHES. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Rash; Unspecified Infection

  MAUDE report 24408243 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PT HAS BEEN USING PW FOR A WHILE. SAID SHE'S NEVER HAD ISSUES BEFORE. SHE THINKS UTI IS COMING FROM THE WICK. ASKED TO STOP AS FOR NOW UNTIL THEY CAN GET SITUATION CLEARED UP. PT IS UNDER HOSPICE CARE SO KIND OF TRYING TO TAKE THEIR DIRECTION ON NEXT STEPS. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN IF LOT/SERIAL NUMBER WAS REQUESTED. NO MEDICAL IMPACT OR MEDICAL INTERVENTION REPORTED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24395548 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SAID SHE IS GETTING UTIS. LOT NUMBER WAS NOT PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24378856 ↗
• InjuryFeb 13, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT ONLY HAS BURNING WITH THE PW WICK; REFUSING TO CONSULT DOCTOR. HAS BURNING IN CLITORIS AREA. ADVISED COULD BE A UTI/YEAST INFECTION. CLAIMING SHE NEVER HAS THOSE AND WILL TRY SOME MEDS. NO MEDICAL INTERVENTION WAS PROVIDED. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. PER CUSTOMER VIA EMAIL ON 11FEB2026 IT WAS REPORTED THAT ALL IT WAS, WAS SOME IRRITATING AND BURNING AT HER PRIVATE AFTER USING THE PURE WHICH FOR A COUPLE WEEKS. NOW WE ARE JUST USING IT FOR BED TIME AND SHE'S BEEN FINE.

  Patient problems: Burning Sensation; Skin Inflammation/ Irritation

  MAUDE report 24338841 ↗
• InjuryJan 23, 2026Decrease in Suction; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AUTHORIZER STATES PW HAS NO SUCTION-T/S WITH KIT PURCHASED LESS THAN A MONTH AGO AND THERE WAS NO SUCTION AT ALL. PU# (B)(4) AND EX ORDER# (B)(4) WERE PROCESSED. SENT BIO-HAZARD BOX. USED WITH FEMALE WICKS. NO ADDITIONAL INFORMATION PROVIDED. TROUBLESHOOTING DID NOT RESOLVED THE ISSUE. (PREPPING AND PLACEMENT TIPS SHARED). PER FOLLOW UP INFORMATION RECEIVED FROM CUSTOMER VIA EMAIL ON 09JAN2025, IT WAS REPORTED THAT THEY CALLED IN THE DEFECTIVE UNIT, WE HAD BEEN USING THE PUREWICK MACHINE FOR 2 YEARS SUCCESSFULLY. WE CHANGED THE ACCESSORIES AS RECENTLY AS NOVEMBER, BUT THE UNIT STOPPED SUCKING IN MID DECEMBER. THE MACHINE STILL TURNED ON AND MADE THE SOFT BUZZING NOISE IT ALWAYS MADE WHEN IT WORKED CORRECTLY. THEIR MOM HAS HAD REPEATED UTIS RECENTLY, BUT THEY DID NOT KNOW IF THAT IS DUE TO THE MACHINE MALFUNCTIONING. THE PRODUCT HAS ALREADY BEEN PACKAGED UP FOR RETURN AND WILL BE PICKED UP TOMORROW.

  Patient problems: Urinary Tract Infection

  MAUDE report 24172897 ↗
• InjuryJan 12, 2026Use of Device Problem

  IT WAS REPORTED THE PATIENT STATES REUSING WICKS AND GETTING UTIS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH FEMALE WICKS. NO ADDITIONAL INFORMATION PROVIDED. IT'S UNCLEAR IF TROUBLESHOOTING WAS PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24032119 ↗