PureWick PW300Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741231001), received between Dec 3, 2025 and Sep 30, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952614 ↗
• MalfunctionSep 29, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940507 ↗
• MalfunctionSep 17, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808566 ↗
• MalfunctionAug 28, 2026Product Quality Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508376 ↗
• MalfunctionAug 20, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50358842 ↗
• MalfunctionJun 19, 2026Decrease in Suction

  IT WAS REPORTED THAT THE PW300 DOES NOT SUCTION. WALKED THROUGH T/S UNIT PASSED WATER CUP TEST. ADVISED THE WICK SHOULD BE PLACED PROPERLY TO SECURE SUCTION. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS RESOLVED. THE LOT/SERIAL NUMBER WAS NOT PROVIDED. NO MEDICAL IMPACT OR INJURY WAS REPORTED. MALE WICKS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566024 ↗
• MalfunctionApr 30, 2026Decrease in Suction

  IT WAS REPORTED THAT THE PUREWICK URINE COLLECTION SYSTEM STOPPED WORKING PROPERLY IT WAS NOT SUCTIONING AT ALL AND IT WAS ALSO MAKING A LOUD NOISE WHEN USING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045484 ↗
• MalfunctionApr 21, 2026Decrease in Suction

  IT WAS REPORTED THAT CUSTOMER STATED THEY WERE HAVING ISSUES WITH THE SUCTIONING. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. THE LOT/SERIAL NUMBER WAS NOT PROVIDED. THERE ARE NO REPORTS OF IMPACT/INJURY TO THE PATIENT. USED WITH MALE WICKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24947623 ↗
• MalfunctionMar 31, 2026Decrease in Suction

  IT WAS REPORTED THAT THERE WAS NO SUCTION - BOUGHT A NEW KIT WILL SEE IF THINGS MAY CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749715 ↗
• MalfunctionFeb 26, 2026Decrease in Suction

  IT WAS REPORTED THAT THE PUREWICK PORTABLE WAS NOT DRAWING AWAY URINE FROM THE PATIENT AFTER MULTIPLE USES AND TRYING DIFFERENT METHODS. THIS WAS CAUSING TOO MUCH MOISTURE ON THE PATIENT, AND THE PATIENT WAS CONSTANTLY WET. THIS WAS TAKING TOO MUCH TIME FOR THE STAFF AND THE PATIENT WAS UNCOMFORTABLE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 24461043 ↗
• InjuryFeb 18, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PURE WICK 300 CAUSED BLEEDING. THE PATIENT HAD TO GO TO THE EMERGENCY ROOM. THE PATIENT'S HUSBAND SAID THIS UNIT IS DANGEROUS AND ASKED FOR A REFUND. USED WITH FEMALE WICKS. NO ADDITIONAL INFORMATION PROVIDED. NO TROUBLESHOOTING WAS PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24378844 ↗
• MalfunctionDec 15, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO T/S AT THIS TIME- STATES IT FELT LIKE THE MACHINE WAS NOT SUCTIONING AT THE RATE NECESSARY TO COLLECT THE URINE. ALSO THE TUBING WAS COMING DISCONNECTED FROM THE EXTERNAL CATHETER WHEN THE PATIENT MOVES, AND THAT THE MACHINE IS VERY LOUD AND MAKES THE PATIENT ANXIOUS. USED WITH MALE WICKS. NO ADDITIONAL INFORMATION PROVIDED. (PREPPING AND PLACEMENT TIPS SHARED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810488 ↗
• MalfunctionDec 9, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE PATIENT STATED THAT PUREWICK URINE COLLECTION SYSTEM WAS TOO SLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23762864 ↗
• MalfunctionDec 3, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE AUTH WANTED TO RETURN THE WHOLE PW300 SYSTEM, SAID IT WAS NOT AS POWERFUL AS THE PW200 WHICH SHE HAS. STATES THE MALE WICKS ARE NOT STICKING AND A URINE RESIDUE IS LEFT IN THE POUCH WHICH DOES NOT HAPPEN WITH THE PW200. FA WILL SEND BIO BOX. NO MEDICAL IMPACT OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707769 ↗