PureWick Urine Collection System PWKIT03Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 00801741185380), received between Sep 25, 2020 and Sep 24, 2026 — classified as 28 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (47 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 101 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889813 ↗
• MalfunctionSep 21, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848699 ↗
• MalfunctionSep 21, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848293 ↗
• MalfunctionAug 6, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165246 ↗
• MalfunctionAug 6, 2026Decrease in Suction

  It was reported that the customer called in and stated that there was no suction, did the water test, it worked and ordered the kit. Offered survey.Per follow up information received via phone on (b)(6) 2026, it was reported that the new kit has resolved the suction issue. Device is working properly.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161552 ↗
• InjuryJul 30, 2026Patient Device Interaction Problem

  It was reported that the Doctor stated that where the tubing touches the pt she is getting a reaction that appears to be whelps. Will consult with Doctor to see if pt has potential PVC allergy. 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)2026 it was reported, medical treatment done.

  Patient problems: Local Reaction

  MAUDE report 50084489 ↗
• MalfunctionJun 17, 2026Decrease in Suction

  IT WAS REPORTED THAT THE CUSTOMER CALLED REGARDING NO SUCTIONING ON THE CANISTER. A TROUBLESHOOT WAS CONDUCTED AND THERE STILL WAS NO SUCTIONING, A P/U WAS PLACED ON HER BEHALF. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH MALE WICKS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25538202 ↗
• MalfunctionApr 1, 2026Decrease in Suction

  IT WAS REPORTED BY THE CUSTOMER THAT THE PUREWICK URINE COLLECTION SYSTEM CANISTER HAD NO SUCTION. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758850 ↗
• MalfunctionMar 31, 2026Decrease in Suction

  IT WAS REPORTED THAT THE PUREWICK KIT HAD NO SUCTION. CUSTOMER CONDUCTED A WATER TEST, AND IT FAILED. NO INJURY REPORTED. THEY ADVISED TO REACH OUT TO THEIR BARD FIELD ASSURANCE TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749710 ↗
• MalfunctionMar 31, 2026Decrease in Suction

  IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT USED THE PRODUCT PUREWICK ACCESSORIES REPLACEMENT KIT. IT WAS REPORTED BY THE CUSTOMER THAT THE PRODUCT DID NOT SUCTION DURING THE WATER TEST AND FAILED TO PULL ANY WATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741656 ↗
• MalfunctionMar 20, 2026Decrease in Suction

  IT WAS REPORTED THAT CUSTOMER STATED THE PUREWICK ACCESSORIES REPLACEMENT KIT DID NOT ASSIST THE MACHINE TO SUCTION. PATIENT LOCATED A PREVIOUS KIT NOT USED AND REPLACED THAT AND MACHINE STARTED WORKING FINE. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649595 ↗
• MalfunctionFeb 23, 2026Decrease in Suction

  IT WAS REPORTED THAT THE PATIENT STATED THE PUREWICK KIT HAD NOT BEEN SUCTIONING TO THE BEST OF ITS ABILITY AND FAILED WATER. THEY HAVE REQUESTED THAT THE CUSTOMER WORK DIRECTLY WITH THE MANUFACTURER FIRST TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422031 ↗
• MalfunctionFeb 18, 2026Decrease in Suction; Physical Resistance/Sticking

  IT WAS REPORTED THAT CUSTOMER CALLED IN STATING THAT THE SYSTEM ISN'T SUCTIONING AND SHE WOULD LIKE TO GET A REPLACEMENT KIT AS THE ONE SHE HAS ISN'T WORKING AS IT IS NOW WORKING. CUSTOMER WILL CB TO T/S. USED WITH MALE WICKS. NO ADDITIONAL INFORMATION PROVIDED. IT'S UNCLEAR IF TROUBLESHOOTING WAS PROVIDED (PREPPING AND PLACEMENT TIPS SHARED) PER FOLLOW UP INFORMATION RECEIVED ON 12FEB2026, IT WAS REPORTED PATIENT, STEVEN TEPPER WAS HOSPITALIZED OVER THE WEEKEND (APPENDICITIS/APPENDECTOMY), SO THE UNIT IN QUESTION IS BACK AT HIS FACILITY. THIS ISSUE WAS POOR/LOW/NO SUCTION OF THE CANISTER. DESPITE ALL TROUBLESHOOTING EFFORTS AS DEMONSTRATED IN THE VIDEOS, SUCTION STILL FAILED, RESULTING IN AN OVERFLOWING POUCH AND MESS FOR THE PATIENT. THE FLOATING MECHANISM WAS STUCK, EVEN THOUGH IT WAS SHAKEN/TAPPED AS INSTRUCTED IN THE TROUBLESHOOTING VIDEO. THE FACILITY WAS ABLE TO REPLACE WITH A SMALLER SUCTION CANISTER SO THAT MY HUSBAND COULD CONTINUE TO USE THE PUREWICK SYSTEM AND IT WORKED GREAT. I HAVE SINCE ORDERED A NEW CANISTER, BUT HAVE YET TO INSTALL IT, DUE TO STEVEN'S UNEXPECTED HOSPITALIZATION. I DO NOT HAVE ACCESS TO THE UNIT AND ITS IDENTIFYING NUMBERS, BUT I CAN SEE IF I CAN GE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378473 ↗
• MalfunctionJan 30, 2026Decrease in Suction

  IT WAS REPORTED THAT THE CAREGIVER STATES THE PATIENT ISSUE; LONGER TUBE, WORRY ABOUT SUCTION, CB SET FOR (B)(6) 2026 @ 10AM. USED WITH MALE WICKS. NO ADDITIONAL INFORMATION PROVIDED.\ IT'S UNCLEAR IF TROUBLESHOOTING WAS PROVIDED. (PREPPING AND PLACEMENT TIPS SHARED) PER (B)(6), VIA PHONE ON (B)(6) 2026 IT WAS REPORTED, NO T/S DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228772 ↗
• MalfunctionJan 26, 2026Decrease in Suction

  IT WAS REPORTED THAT THE CUSTOMER IS HAVING ISSUES WITH SUCTION SINCE YESTERDAY. IT STALLS OUT IN THE TUBE AND WON'T GO IN TO THE CONTAINER. CALLING BACK WITH UNIT AND PROVIDED THE LOT NUMBER. CHECKED THE FLOAT VALVE; PERFORMED SUCTION TEST TOOK ABOUT 10 SECS TO START SUCTION TESTED AGAIN AND THEN IT WAS ALMOST IMMEDIATELY. NO ADDITIONAL INFORMATION PROVIDED. TROUBLESHOOTING RESOLVED THE ISSUE. (PREPPING AND PLACEMENT TIPS SHARED). PER CUSTOMER, VIA PHONE ON 21JAN2026 IT WAS REPORTED TROUBLESHOOT DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185417 ↗
• InjuryJan 12, 2026Disconnection

  IT WAS REPORTED THE CUSTOMER SAID THE HOSE DOES NOT STAY CONNECTED TO THE WICK CAUSING TONS OF LEAKAGE AND SORES FROM URINE SITTING. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN IF LOT/SERIAL NUMBER WAS REQUESTED. USED WITH FEMALE WICKS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 24032142 ↗
• MalfunctionDec 16, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT PUREWICK ACCESSORIES REPLACEMENT KIT PATIENT HAD NO SUCTION, FAILED TROUBLESHOOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822270 ↗
• MalfunctionDec 15, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE DEVICE WAS DOING WELL AT FIRST. STATED BOUGHT SOME AFTERMARKET HOSE AND IT WASN'T WORKING AND ENDED UP BUYING SOME FROM US AND IT DID NOT WORK WELL. NO TO LOW SUCTION. SUGGESTED HOSPITAL MESH UNDERWEAR, FEMININE PADS, AND DIAPER. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH FEMALE FLEX MALE WICKS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 16DEC2025, IT WAS REPORTED, T/S NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811716 ↗
• MalfunctionNov 26, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT (B)(4) NOTED RECENT ISSUE WITH JARROD'S PW DEVICE NOT SUCTIONING AND IT WAS DETERMINED ISSUE WITH LID. WANTS TO KNOW IF DEFECTIVE OR IF THIS IS A COMMON ISSUE AND HOW TO PREVENT. ALSO WANTED TO REVIEW CLEANING INSTRUCTIONS. EMAILING HIM CLEANING INSTRUCTIONS AND NOTED TO USE WATER WITH DISH SOAP AND 70% ISOPROPYL ALCOHOL. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN IF LOT/SERIAL NUMBER WAS REQUESTED. NO MEDICAL IMPACT OR MEDICAL INTERVENTION REPORTED. USED WITH MALE WICKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657534 ↗
• MalfunctionNov 14, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE PUREWICK ACCESSORY REPLACEMENT KIT FAILED SUCTION TEST. WE HAVE REQUESTED THAT THE CUSTOMER WORK DIRECTLY WITH THE MANUFACTURER FIRST TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555286 ↗
• MalfunctionNov 11, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE PATIENT STATED PUREWICK HAS FAILED WATER TROUBLESHOOTING. THEY HAVE REQUESTED THAT THE CUSTOMER WORK DIRECTLY WITH THE MANUFACTURER FIRST TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23527020 ↗
• MalfunctionNov 11, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE PUREWICK ACCESSORIES REPLACEMENT KIT NOT SUCTIONING. THEY HAVE REQUESTED THAT THE CUSTOMER WORK DIRECTLY WITH THE MANUFACTURER FIRST TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525813 ↗
• MalfunctionOct 27, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE CUSTOMER STATES PW WILL NOT SUCTION. REP RESET FLOAT VALVE. PW FAILED WATER CUP TEST EXCHANGING ACCESSORY KIT IF ISSUE PERSIST. CUSTOMER WILL NEED TO PURCHASE NEW UNIT; OOP WARRANTY EXPIRED IN 2024. NO ADDITIONAL INFORMATION PROVIDED. TROUBLESHOOTING DID NOT RESOLVED THE ISSUE. BIO BOX NEEDED FROM FIELD ASSURANCE FOR KITS/WICKS ONLY. (PREPPING AND PLACEMENT TIPS SHARED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390563 ↗
• MalfunctionOct 22, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE PATIENT STATES HIS PUREWICK ISN'T SUCTION AT ALL. REP DID A T/S WITH THE NEW KIT AND THE WATER SUCTIONED OUT SUCCESSFULLY. USED WITH MALE WICKS. NO ADDITIONAL INFORMATION PROVIDED.\ TROUBLESHOOTING RESOLVED THE ISSUE. (PREPPING AND PLACEMENT TIPS SHARED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23358680 ↗
• MalfunctionOct 17, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE CUSTOMER SAID PW FAILED THE WATER TEST AFTER REPLACEMENT KIT. REP SENDING REPLACEMENT PW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324393 ↗