PureWick PWMX30Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00801741226465), received between Nov 20, 2024 and Sep 25, 2026 — classified as 1 death, 49 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (31 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Insufficient Information; Urinary Tract Infection

  MAUDE report 50903530 ↗
• MalfunctionSep 11, 2026Decrease in Suction

  It was reported that PT said my machine rattles and causes condensation from the wick and it gurgles a lot this should be fixed is my suggestion. Used with male wicks. Unclear if medical intervention was provided.No additional information provided.As per customer follow up information received via email on 26Jun2026, I was calling because the machine seems to gurgle urine all night. It also leaves condensation under the bag between the bag and body because of some urine sitting in the bag. It¿s not a lot. It¿s a very small amount here and there but enough to be gurgling all night and leave the condensation. I have since realized this is because the suction is not quite strong enough. It shouldn¿t gurgle trying to get all the urine up all night long and if it was clearing the bag, it wouldn¿t have condensation. Like I said, I¿ve used other machines before and your bags without this issue. I really think the new machine needs a slightly stronger suction. I was very disappointed when the nurse service member told me on the phone the rattling of the lid was the problem and it rattles when it gets wet. So that¿s why it¿s gurgling. I knew this was not the case because, I ordered an extra

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734679 ↗
• InjurySep 10, 2026Fitting Problem

  It was reported that the Attorney-in-Fact for a patient/caregiver who uses the male Bard external catheters at home, supplied through Liberator Medical Supplies. Product Name, catalog number, serial number: BD PureWick portable collection system; PW300; DYKXST0709.Customer have seen that the tubing connector on the home-use catheters was flat/smooth, in contrast to the ribbed connector used on catheters customer have received during hospital stays. In practical use, this difference has resulted in an inconsistent seal between the catheter and collection tubing, intermittent leaking at the connection point, and reduced suction. Urine has been left standing in the catheter as a result, and they have experienced recurrent urinary tract infections that they believe are connected to this connection failure.It was unknown what medical intervention was provided for urinary tract infection.

  Patient problems: Urinary Tract Infection

  MAUDE report 50718392 ↗
• MalfunctionSep 9, 2026Decrease in Suction

  It was reported that a design defect in the home use PureWick system tubing connection, resulted in loss of suction, stagnant fluid accumulation, and recurrent Urinary Tract Infections (Utis). A critical quality and design disparity between the PureWick system utilized in hospital settings and the version distributed for home care use. ""[Profanity]"" configuration. The catheter tubing was reported to have securely attached to a robust, ribbed connector that ensures a stable, cohesive seal with the tubing. The home version of external catheters lacked any ribbed or secure locking mechanism, and the connection rapidly degraded. While the manufacturer recommended this tubing every 90 days at a cost of $182 per line, the tubing realistically maintained adequate physical placement for no more than 40 days. This poor connection caused two severe issues: Suction Failure, where the lack of a cohesive seal drastically limited the system's vacuum/suction capacity and stagnant fluid & Infection, where urine failed to clear the line properly due to compromised suction and remained stagnant and festers within the catheter assembly. As a direct consequence of this design flaw and the resulting

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692482 ↗
• InjurySep 5, 2026Patient Device Interaction Problem

  Patient problems: Rash

  MAUDE report 50634874 ↗
• MalfunctionAug 27, 2026Decrease in Suction

  It was reported that the patient's granddaughter stated the urine is polling in the wick and the urine is backlogged and starts leaking under the scrotum. Eighteen wicks were bad. It is unclear if troubleshooting was performed. No impact or injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50476007 ↗
• InjuryAug 26, 2026Biocompatibility

  It was reported that the customer's husband said had a bad allergic reaction from using Purewick from the adhesive. Customer also got blisters and had to get on antibiotics and took 3 weeks to heal. The issue started once he started using Purewick. He is feeling better not but wife called to make sure we have insurance send monthly supply. It's unclear if lot number was requested. Unclear if medical intervention was provided. No additional information provided.

  Patient problems: Blister; Hypersensitivity/Allergic reaction

  MAUDE report 50456174 ↗
• MalfunctionAug 23, 2026Decrease in Suction

  It was reported that her son's PW was not functioning properly. She stated the urine was sitting in the catheter portion and was not suctioning away. She was worried this would cause a UTI. She was also concerned with how many MECs she was going through because she had been replacing it every time, he urinated so he wasn't sitting in it. No medical intervention was reported. Discussed further with patient. She believes he is sitting in the urine as the gauze is slightly tinted yellow, meaning it is wet still. Confirmed there is no urine pooled in the bottom of the MEC, just the color changed gauze. Discussed how it is possible that the urine may stain the gauze giving the appearance of still being wet. The PureWick Male External Catheter wicking material dries within 25 minutes leaving no residual urine. Discussed proper placement and confirmed no lotions and ointments are being used. Inquirer spoke to a BD Rep yesterday and placed the tubing in a cup of water to which it suctioned away fine. This rep (no case found in the system from Medical Information team). Told inquirer she can try the female PureWick if male PureWick isn't working. Explained the female PureWick is only indica

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50397075 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Urinary Tract Infection

  MAUDE report 50382850 ↗
• InjuryAug 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient has UTI. It is unknown if troubleshooting was performed. Lot or serial number was not provided.

  Patient problems: Urinary Tract Infection

  MAUDE report 50268367 ↗
• MalfunctionAug 14, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261300 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the PT's Daughter requested return. She said PT got an infection from male wicks in the hospital and is now uncomfortable using device at home. Unopened and Unused. Customer also requested for automatic shipping to be cancelled, automatic shipping cancelled. 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.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 50208692 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the customer stated that the patient is getting infections. It's unclear if lot number was requested. Unclear if medical intervention was provided. No additional information provided.

  Patient problems: Unspecified Infection

  MAUDE report 50091037 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN ADVERSE EVENT REPORTED AS POSSIBLY RELATED TO THE PUREWICK MALE EXTERNAL CATHETER. THE ADVERSE EVENT WAS REPORTED IN CLINICAL STUDY UCC-25HC015. THE ADVERSE EVENT IS SEVERE CHEST PAIN STARTING ON (B)(6) 2026 REQUIRING HOSPITALIZATION.

  Patient problems: Chest Pain

  MAUDE report 25562898 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AFTER USING PUREWICK FOR 8 DAYS AND WERE TOLD POSSIBLY IT WAS CAUSED FROM THE PUREWICK. NO OPEN WOUNDS OR SORES IN THAT AREA. SHE CALLED (B)(6) AND THEY ADVISED HER TO CALL THE MANUFACTURE. APOLOGIZED & TRANSFERED TO CUSTOMER SERVICE TO ASSIST. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. NO TROUBLESHOOTING WAS PROVIDED. (PREPPING AND PLACEMENT TIPS SHARED) IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 24891558 ↗
• InjuryApr 14, 2026Fluid/Blood Leak

  PT STATED THAT IT IS NOT THE PUMP THAT IS BAD IT IS THE POUCHES, SHE USED AN OLD POUCH AND THE POUCH WORKED FINE BUT THE NEW CS SHE RECEIVED IS BAD AND NOT ABLER TO SUCTION THE URINE. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. PER CUSTOMER VIA EMAIL ON (B)(6) 2026, THERE WAS IMPACT TO THE PATIENT. PATIENT GOT A URINARY TRACT INFECTION BECAUSE OF NIGHTLY LEAKING FROM THE FAULTY WICKS AND IS NOW BEING HOSPITALIZED DUE TO SAID INFECTION. THERE ARE UNUSED WICKS AVAILABLE BUT NOT USED ONES. BEFORE ANY OTHER CHANGES WERE MADE TO SYSTEM, WICKS FROM A DIFFERENT LOT WERE USED WHICH RESOLVED THE LEAKING. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24879610 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PT SAID USED FOR A WEEK AND DEVELOPED A YEAST INFECTION IN HIS GROIN AND DISCONTINUED USE. HUNG UP DURING TRANSFER TO CUSTOMER SERVICE; EMAILED SUPERVISORS. 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.

  Patient problems: Fungal Infection

  MAUDE report 24816058 ↗
• MalfunctionApr 1, 2026Decrease in Suction

  IT WAS REPORTED THAT THE CUSTOMER STATES THAT THEY ARE HAVING ISSUES WITH THE PWMX30 NOT SUCTIONING. WE DID THE WATER TEST AND IT PASSED. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS NOT RESOLVED. IT IS UNCLEAR IS LOT OR SERIAL NUMBER WAS PROVIDED. NO MEDICAL IMPACT OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758842 ↗
• MalfunctionApr 1, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A REGISTERED NURSE SPOKE TO THE SON WHO PURCHASED DEVICE FOR HIS FATHER. HIS FATHER COMPLAINED OF A BURNING SENSATION. ON THE TOP PART OF THE MALE WICK, AROUND TOP VENT AREA. CLIENT HAD BEEN NEARING THE 24 HOUR MARK WITH HIS WICK. IT ALSO LOOKED DISCOLORED. THE SON WAS WONDERING HOW PEE COULD GET THERE. REGISTERED NURSE CLARIFIED DUE TO HIM UNABLE TO HOLD HIS PENIS AND DIRECT IT DOWNWARDS SOMETIMES IT CAN MOVE AND LAND SOMEWHERE ELSE. CLIENT WAS ALSO WORRIED ABOUT THE SWEAT ON HIS BACK FROM LAYING ALL NIGHT. REGISTERED NURSE ENCOURAGED TO USE BLUE PADS UNDERNEATH AND ENSURING HE IS GETTING TURNED. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN IF LOT OR SERIAL NUMBER WAS REQUESTED. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 05MAR2026,IT WAS REPORTED HE WAS PRESCRIBED ANTIBIOTICS DUE TO THE BURNING SENSATION IN HIS PENIS. IT WAS BELIEVED TO BE AN UTI. THE SON ALSO STATED THAT HE NOTICED THAT URINE WAS POOLING IN THE MALE WICK. I REFERRED HIM TO LMS FOR TROUBLESHOOTING TO MAKE SURE THAT THE UNIT IS SUCTIONING PROPERLY. HE WILL HAVE HIS FATHER'S CAREGIVER TO CALL.

  Patient problems: Burning Sensation

  MAUDE report 24758364 ↗
• MalfunctionMar 25, 2026Decrease in Suction

  PT STATED THAT IT IS NOT THE PUMP THAT IS BAD IT IS THE POUCHES, SHE USED AN OLD POUCH AND THE POUCH WORKED FINE BUT THE NEW CS SHE RECEIVED IS BAD AND NOT ABLER TO SUCTION THE URINE. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690649 ↗
• MalfunctionMar 10, 2026Decrease in Suction; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER WHO SAYS THAT HE IS EXPERIENCING SOME LEAKAGE WITH HIS MALE PW. HE SAYS HE HAS ALREADY DONE OR IS DOING EVERYTHING I SUGGESTED AS FAR AS MAKING SURE HIS PRIVATE AREA IS CLEANED WITH SOAP AND WATER BEFORE APPLYING THE WICK. PRESS FIRMLY ON THE ADHESIVE TO MAKE SURE IT IS STICKING PROPERLY BUT IT IS STILL LEAKING AND NOT COLLECTING ANYTHING, ALSO MAKES LOUD OBNOXIOUS SOUNDS AND GURGLING SOUNDS. RN ADVISED THE PATIENT TO MAKE SURE TUBING IS TIGHT AND SECURE ALSO TO TRY SWITCHING TUBE ENDS. CALLBACK SCHEDULED FOR TOMORROW TO TRANSFER TO CS FOR REPLACEMENT UNIT. SURVEY OFFERED. NO ADDITIONAL INFORMATION PROVIDED. NO TROUBLESHOOTING WAS PROVIDED. (PREPPING AND PLACEMENT TIPS SHARED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24565285 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS IN RESPONSE TO A SURVEY. THE AUTHORIZED REPRESENTATIVE ADVISED THAT THE PATIENT GOT A BAD UTI WHILE USING THAT CONTRIBUTED TO HIS DEATH. AUTH SAID THEY WERE MODERATELY DIFFICULT TO LEARN HOW TO USE. AUTH STRONGLY DISAGREES THAT THIS HELPS KEEP PATIENTS OUT OF LONG-TERM CARE FACILITIES. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION FOR URINARY TRACT INFECTION. A BD REPRESENTATIVE ATTEMPTED FOLLOW UPS TO OBTAIN ADDITIONAL INFORMATION VIA PHONE ON 18FEB2026, 20FEB2026, AND 22FEB2026 AND VIA EMAIL ON 20FEB2026, AND 22FEB2026. NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 24448090 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER STATES THAT THEY WAS USING THE PUREWICK THEN CAUGHT A UTI. STOPPED USING THE PUREWICK NOW WANTS TO RETURN AN UNOPENED BOX. 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 24444975 ↗
• MalfunctionFeb 23, 2026Decrease in Suction

  IT WAS REPORTED THAT THE PATIENT ADVISED THERE ARE OCCASIONAL ADHESION PROBLEMS AS WELL AS THE URINE SOMETIMES STAYING IN THE WICKS AND NOT SUCTIONING ALL THE WAY. PATIENT ALSO ADVISED THE WICK IS SLIGHTLY UNCOMFORTABLE TO REMOVE. NO ADDITIONAL INFORMATION PROVIDED. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN IF LOT/SERIAL NUMBER WAS REQUESTED. NO MEDICAL IMPACT OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422034 ↗
• MalfunctionFeb 20, 2026Decrease in Suction

  IT WAS REPORTED THAT THE CUSTOMER STATES LEAKS, STRANGE SUCTION SOUND. ISSUE RESOLVED BY TROUBLESHOOT LEAKS. TROUBLESHOOT SUCTION, SUGGESTED DOING THE WATER TEST AND MAKING SURE ALL TUBING IS SECURE AND IN PLACE. MALE USE. TIPS ON HOW TO MAKE THE SEALANT STICK TO THE SKIN. MAKE SURE SKIN IS DRY. TRIM PUBIC HAIR. DO NOT SHAVE AS THAT CAN CAUSE IRRITATION WITH THE ADHESIVE. MAKE SURE YOU ARE NOT USING ANY LOTIONS OR SOAPS ON THE AREA. LEAKS. CUSTOMER DESCRIBES LEAKS, TROUBLE SHOOT DIRECTED AT UNCOVERING VENT HOLE, PLACING CANISTER BELOW THE LEVEL OF THE BLADDER AND ENSURING CORRECT WICK/CATHETER PLACEMENT. NO ADDITIONAL INFORMATION PROVIDED. (PREPPING AND PLACEMENT TIPS SHARED). PER FOLLOW UP INFORMATION RECEIVED ON 10FEB2026, IT WAS REPORTED CALLER STATES HUSBAND IS CURRENTLY NO LONGER USING THE DEVICE AS HIS CONDITION IS IMPROVED. HOWEVER, WE WERE EXPERIENCING SUCTION AND NOISE PROBLEMS PRIOR TO HIM DISCONTINUING USE. IT WAS NOT LEAKING. I WAS UNABLE TO HEAR THE NOISE, BUT IT WAS DISRUPTIVE TO MY HUSBAND. I APPRECIATE THE TROUBLE SHOOTING VIDEO YOU RECENTLY SENT AND WILL VIEW THAT IF WE START TO USE THE PRODUCT IN THE FUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24406874 ↗