PureWick PWFXH30Recalls & reported problems

Summary

The FDA's MAUDE database contains 230 adverse event reports that list this exact device (DI 00801741226984), received between Nov 18, 2024 and Sep 30, 2026 — classified as 197 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (35 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 230 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Decrease in Suction

  Patient problems: Urinary Tract Infection

  MAUDE report 50952615 ↗
• MalfunctionSep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Urinary Tract Infection

  MAUDE report 50952613 ↗
• MalfunctionSep 29, 2026Increase in Suction

  Patient problems: Pain

  MAUDE report 50940869 ↗
• InjurySep 28, 2026Patient Device Interaction Problem

  Patient problems: Insufficient Information

  MAUDE report 50924416 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Urinary Tract Infection

  MAUDE report 50923642 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the PT said that got infection last (b)(6), and that she didn't see any literature regarding the cleaning of the canister and tubing. Informed her that cleaning should be with dishwashing detergent and isopropyl alcohol 70% also informed her that we will take note regarding her concern about instructions in cleaning kits. It's unclear if lot number was requested.Unclear if medical intervention was provided.No additional information provided.

  Patient problems: Unspecified Infection

  MAUDE report 50917204 ↗
• InjurySep 28, 2026Biocompatibility

  It was reported that the customer is having an allergic reaction to the flex wicks. States she believes it may be from the dye or coloring of the wicks but isn't entirely sure. She has brought this up to her provider and requested for them to contact the distributor on her behalf and advocate for her. Apologized and explained that via insurance, only the flex wicks are covered, and patient would have to purchase the original blue wicks out of pocket if she preferred them. She asked if there is any documentation of her doctor calling the distributor. Advised not in relation to her reaction. Again, offered to exchange the wicks for a new box but patient claimed that she received an order of flex wicks twice and has had a reaction. So, she is not interested in another box, nor does she believe this is a one-off scenario. She prefers the original wicks, states she never had this issue with them. It's unclear if lot number was requested. Unclear if medical intervention was provided. No additional information provided. Patient states she will call her doctor.Per customer via email on (b)(6) 2026, it was reported that she has been buying female blue catheters for years with no problems. I

  Patient problems: Hypersensitivity/Allergic reaction; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 50916293 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Spouse of the Patient states his wife got a UTI from PW. Unclear if medical intervention was provided. It's unclear if lot number was requested. No additional information provided.

  Patient problems: Urinary Tract Infection

  MAUDE report 50916263 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the PT said the last time she used it the wicks caused her an infection so she's wanting to cancel the order and won't be using. It was unknown what medical intervention was provided. No additional information provided. It's unclear if lot number was requested.

  Patient problems: Unspecified Infection

  MAUDE report 50899368 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Urinary Tract Infection

  MAUDE report 50889831 ↗
• InjurySep 24, 2026Patient Device Interaction Problem

  Patient problems: Urinary Tract Infection

  MAUDE report 50889810 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Urinary Tract Infection

  MAUDE report 50809428 ↗
• InjurySep 17, 2026Product Quality Problem

  Patient problems: Unspecified Infection

  MAUDE report 50809427 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  It was reported that a customer complained that she has a cut on her vagina with Pure Wick Flex Catheter. 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.Per customer via email on 01SEPT2026 it was reported that the purple material on the flex catheter causes cutting to the vaginal tissue that causes white bacterial growth including bleeding.

  Patient problems: Bacterial Infection; Insufficient Information; Laceration(s)

  MAUDE report 50802949 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50781987 ↗
• InjurySep 11, 2026Patient Device Interaction Problem

  Patient problems: Burning Sensation

  MAUDE report 50741623 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's spouse states that the patient stopped using Pure Wick for a while due to an infection, says she will start to use again in a week. It's unclear if lot number was requested. Unclear if medical intervention was provided. No additional information provided.

  Patient problems: Unspecified Infection

  MAUDE report 50741619 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Urinary Tract Infection

  MAUDE report 50722268 ↗
• MalfunctionSep 9, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fungal Infection

  MAUDE report 50700905 ↗
• InjurySep 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Irritability; Skin Inflammation/ Irritation; Urinary Tract Infection

  MAUDE report 50639395 ↗
• InjurySep 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fungal Infection

  MAUDE report 50636921 ↗
• InjuryAug 28, 2026Disconnection

  It was reported that they circling back on another injury related to the Purewick Female External Catheter disconnecting from the tubing, which resulted in a blister on the patient's abdomen. When they discussed that, they emphasized the importance of connecting the device to suction before applying that to the patient. That appeared that staff would benefit from reeducation on the proper application process. They wanted to share that information and pass that along for continued education planning.Per additional information received via email on 25-AUG-2026 stated that there was a third incident that was reported last week. No physical samples available. They did not have a lot or serial number of the Purewick flex or suction tubing. Patient details are age 89, white, female, 125 lbs, 5 ft tall. I cannot provide birthday or name of patient. The patient sustained a blood blister and the area was treated with wound cleanser and a bordered foam dressing by nursing. She was discharged and not seen by Wound Care Team.

  Patient problems: Blister

  MAUDE report 50499332 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that customer stated that they got UTI. The reason is unknown and stated that customer still needs to see a doctor.It is unclear if troubleshooting was performed.Lot/Serial number was no provided.

  Patient problems: Urinary Tract Infection

  MAUDE report 50479635 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Urinary Tract Infection

  MAUDE report 50420796 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Patient said the Flex wicks area causing irritation and yeast infection. It's unclear if lot number was requested. It was unknown what medical intervention was provided. No additional information provided.

  Patient problems: Fungal Infection; Skin Inflammation/ Irritation

  MAUDE report 50414146 ↗