PureWick Urine Collection SystemRecalls & reported problems across all models

We found 3 models of PureWick Urine Collection System by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 1,096 adverse event reports in the FDA's MAUDE database, received between Jun 12, 2020 and Sep 30, 2026 — classified as 152 injuries, 944 malfunctions.

The most frequently reported specific device problem is “Decrease in Suction” (696 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported PureWick Urine Collection System problems

PureWick Urine Collection System models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PureWick Urine Collection System PW200

  Collector, urine, powered, non indwelling catheter
  501 reports
• PureWick Urine Collection System PW100

  Collector, urine, powered, non indwelling catheter
  494 reports
• PureWick Urine Collection System PWKIT03

  Collector, urine, powered, non indwelling catheter
  101 reports

Recent PureWick Urine Collection System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953975 ↗
• MalfunctionSep 30, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952611 ↗
• MalfunctionSep 30, 2026Decrease in Suction

  It was reported that the Pure Wick Urine Collection System experience an issue when the suction function was initiated. According to the report, once the system began suctioning, fluid accumulated within the device and subsequently leak, resulting in improper operation and potential containment failure. The customer indicated that the leakage consistently occurred during use when suction starts, preventing the device from functioning as intended.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951851 ↗
• MalfunctionSep 30, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950579 ↗
• MalfunctionSep 29, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941216 ↗
• MalfunctionSep 29, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940866 ↗
• MalfunctionSep 29, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938992 ↗
• MalfunctionSep 28, 2026Increase in Suction

  Patient problems: Discomfort

  MAUDE report 50924413 ↗
• MalfunctionSep 28, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924409 ↗
• MalfunctionSep 28, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917212 ↗
• MalfunctionSep 28, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917206 ↗
• MalfunctionSep 28, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916287 ↗
• MalfunctionSep 28, 2026Decrease in Suction

  It was reported that the customer contacted Customer Support to report a suspected product malfunction involving the PureWick¿ PW100 Device. The customer stated that the device did not appear to be functioning properly and that multiple attempts were made to use the product without success. According to the customer, the issue appeared to be related to a lack of suction, as the device was not providing the expected performance during use. The customer reported that several troubleshooting attempts were made; however, the problem persisted. Due to the repeated failure of the device to generate or maintain adequate suction, the customer believed the product might be defective. The complaint was documented as a potential product malfunction related to the suction functionality of the PureWick¿ PW100 Device. Further investigation was required to determine the root cause of the reported issue and assess whether the device met product specifications. The lot number was not available at the time of the call.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916275 ↗
• MalfunctionSep 28, 2026Decrease in Suction

  It was reported that the Patient said the unit isn't suctioning and causing the wicks to leak. Did trouble shoot with the unit plugged into the wall, the unit passed the test. Informed the Patient unit should only be used plugged into the wall. It's unclear if lot number was requested. Used with male wicks.No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916266 ↗
• MalfunctionSep 25, 2026Decrease in Suction

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903551 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports