PureWick PWF030KXRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741226953), received between Nov 5, 2024 and Apr 15, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Increase in Suction; Patient Device Interaction Problem

  IT WAS REPORTED BY THE WOCN NURSE STATED THAT 5 SEPARATE INJURIES RELATED TO PUREWICK FLEX SINCE (B)(6). CUSTOMER STATED 2 OF THE INJURIES WERE STAGE 2 PRESSURE INJURIES, TWO WERE A STAGE 3, AND ONE IS UNSTAGEABLE. ALL WERE LINEAR IN SHAPE AND EITHER NEAR PENIS OR RECTUM. CUSTOMER REQUIRED FOLLOW UP AS SOON AS POSSIBLE. CUSTOMER STATED THAT THEY HAD PICTURES BUT WAS UNABLE TO EMAIL THEM. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2026, UPON REVIEW OF THE REPORTED EVENTS, IT WAS IDENTIFIED THAT HIGHER SUCTION SETTINGS WERE BEING UTILIZED WITH THE DEVICE. ALL AFFECTED PATIENTS WERE ASSESSED, AND THE IDENTIFIED WOUNDS WERE TREATED IN ACCORDANCE WITH STANDARD WOUND CARE PROTOCOLS. FEMALE PUREWICKS WERE REMOVED AND NOT REAPPLIED. STAFF NOTICED THAT THE WHITE MATERIAL ON THE PUREWICK WAS STICKING TO THE SKIN, SOMETHING NOT SEEN WITH THE ORIGINAL PUREWICK. PATIENT 1 EXPERIENCED UNSTAGEABLE PRESSURE INJURY IN INNER BUTTOCKS, PATIENT 2 EXPERIENCED STAGE 2 DEEP TISSUE PRESSURE INJURY IN THIGH, PATIENT 3 EXPERIENCED STAGE 2 PRESSURE INJURY IN LABIA, PATIENT 4 EXPERIENCED STAGE 3 PRESSURE INJURY IN LABIA AND PATIENT 5 EXPERIENCED STAGE 3 PRESSURE INJURY IN LABIA.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 24889391 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SINCE REIMPLEMENTATION OF EXTERNAL CATHETERS AS AN ALTERNATIVE TO INDWELLING CATHETER REPLACEMENT, (B)(6) HAS ALREADY EXPERIENCED AN INCREASE IN SYMPTOMATIC URINARY TRACT INFECTION RATES WITH MOST CASES INVOLVING AN EXTERNAL CATHETER. EXPLORING ROOT CAUSES ARE UNDERWAY. (B)(6) IMPLEMENTED PUREWICK FLEX (PWF030KX) AND PUREWICK MALE (PWM030) SEVERAL MONTHS AGO. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24445552 ↗
• InjuryDec 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE SILICONE CASING OF PUREWICK FLEX CAUSE A PRESSURE SORE ON PATIENT'S VAGINA. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23735148 ↗
• InjuryNov 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT ACQUIRED A TRAUMATIC INJURY FROM PUREWICK FLEX PWF030KX. THE MATTER IS OF GREAT CONCERN AND WOULD APPRECIATE FOLLOW UP. IT HAPPENED IN PCCU. SWELLING OF THE LABIA. THE DEVICE WAS ATTACHED TO PATIENT LABIA WHERE WICKING MATERIAL MEETS RUBBER. DEVICE WAS CHANGED A SHIFT CHANGE. LINEAR PINCH AND SWOLLEN ACCORDING TO WOCN. NO MEDICAL INTERVENTION WAS REPORT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 23497908 ↗
• InjurySep 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT NOTED WITH MULTIPLE BLISTERS INTACT AND SOME BURST CAUSING OPEN AREAS TO BILATERAL LOWER BUTTOCKS AND PERINEUM AREA. IT CAUSED IMMOBILITY, INCONTINENCE - STOOL, INCONTINENCE - URINE, PRESSURE TO SKIN/TISSUE, SKIN MOISTURE. TREATMENT PROVIDED SUCH AS PUREWICK REMOVED, SITE CARE PERFORMED, MOISTURE BARRIER CREAM APPLIED. PER FOLLOW UP ACTIONS PERFORMED ON (B)(6) 2025 SUSPECT PUREWICK INJURY, MOISTURE BARRIER CREAM APPLIED, AND WOUND CARE CONSULTED. RECOMMENDED TO CHANGE AND MONITOR SKIN UNDER PUREWICK EVERY SHIFT AND PRN. ENSURE APPROPRIATE PLACEMENT OF PUREWICK LOCATION.

  Patient problems: Blister; Tissue Breakdown

  MAUDE report 23096543 ↗
• InjuryJul 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THEY HAD 4 DEVICE RELATED SKIN INJURIES SUCTIONING/BLISTERING AT DEARBORN FROM THE PUREWICK EXTERNAL FEMALE CATHETER BECOMING LOOSE/DISLODGED AND THE SUCTION DEVICE SITTING ON THE PATIENT'S SKIN. THERE WERE 2 ADDITIONAL REPORTS OF THIS OCCURRING AT OUR TRENTON HOSPITAL TOO. THEY HAVE DISCUSSED USING THE STATLOCKS DEVICES AND MESH PANTIES FOR SECUREMENT OF THE PUREWICK DEVICE. CUSTOMER WAS EXPRESSING THAT SUCTION TUBING WAS COMING DISCONNECTED FROM PUREWICK FLEX PREMATURELY AND ENDS UP SUCTIONING TO THE PATIENT'S SKIN AND CAUSING BREAKDOWN. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 22531910 ↗
• InjuryJul 14, 2025Disconnection; Disconnection

  TWO SEPARATE SKIN BREAKDOWNS WERE REPORTED BY COREWELL HEALTH PENNOCK. THEY WERE BOTH IN RELATION TO PWF030KX, PUREWICK FLEX. THE FIRST INCIDENT, PUREWICK FLEX DISCONNECTED FROM THE SUCTION TUBING. THE SUCTION TUBING THEN ATTACHED ITSELF ONTO THE PATIENT'S SKIN RESULTING IN A PRESSURE ULCER TYPE WOUND. IT WAS REPORTED TO BE PURPLE/PAINFUL. THE SECOND COMPLAINT WAS REPORTED TO BE FROM THE DEVICE ON THE LABIAL TISSUE. THE DEVICE WAS IN PLACE FOR ROUGHLY 6 HOURS. WHILE BEING ASSESSED, A STAGE 2 PRESSURE ULCER WAS REPORTEDLY FOUND ON THE LABIAL TISSUE OF THE PATIENT. THE DEVICE WAS THEN REMOVED FROM THE PATIENT.

  Patient problems: Pain; Pressure Sore/Ulcer

  MAUDE report 22496264 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO SEPARATE SKIN BREAKDOWNS WERE REPORTED BY (B)(6). THEY WERE BOTH IN RELATION TO PWF030KX, PUREWICK FLEX. THE FIRST INCIDENT, PUREWICK FLEX DISCONNECTED FROM THE SUCTION TUBING. THE SUCTION TUBING THEN ATTACHED ITSELF ONTO THE PATIENT'S SKIN RESULTING IN A PRESSURE ULCER TYPE WOUND. IT WAS REPORTED TO BE PURPLE/PAINFUL. THE SECOND COMPLAINT WAS REPORTED TO BE FROM THE DEVICE ON THE LABIAL TISSUE. THE DEVICE WAS IN PLACE FOR ROUGHLY 6 HOURS. WHILE BEING ASSESSED, A STAGE 2 PRESSURE ULCER WAS REPORTEDLY FOUND ON THE LABIAL TISSUE OF THE PATIENT. THE DEVICE WAS THEN REMOVED FROM THE PATIENT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 22495439 ↗
• InjuryJul 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THEY HAD 4 DEVICE RELATED SKIN INJURIES SUCTIONING/BLISTERING AT DEARBORN FROM THE PUREWICK EXTERNAL FEMALE CATHETER BECOMING LOOSE/DISLODGED AND THE SUCTION DEVICE SITTING ON THE PATIENT'S SKIN. THERE WERE 2 ADDITIONAL REPORTS OF THIS OCCURRING AT OUR TRENTON HOSPITAL TOO. THEY HAVE DISCUSSED USING THE STATLOCKS DEVICES AND MESH PANTIES FOR SECUREMENT OF THE PUREWICK DEVICE. CUSTOMER WAS EXPRESSING THAT SUCTION TUBING WAS COMING DISCONNECTED FROM PUREWICK FLEX PREMATURELY AND ENDS UP SUCTIONING TO THE PATIENT'S SKIN AND CAUSING BREAKDOWN. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 22458266 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION DUE TO THE USE OF THE PUREWICK FLEX FEMALE EXTERNAL CATHETER AND THE PATIENT REQUIRED A MEDICAL OR SURGICAL INTERVENTION AND THE DOCTOR PRESCRIBED ANTIBIOTICS. THE PRODUCT WAS USED BETWEEN 1 TO 3 WEEKS AGO.

  Patient problems: Urinary Tract Infection

  MAUDE report 20620284 ↗
• InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION DUE TO THE USE OF THE PUREWICK FLEX FEMALE EXTERNAL CATHETER AND THE PATIENT REQUIRED A MEDICAL OR SURGICAL INTERVENTION. THE PRODUCT WAS USED BETWEEN 1 TO 3 WEEKS AGO.

  Patient problems: Urinary Tract Infection

  MAUDE report 20610131 ↗