Bardex® Lubricath® Foley Catheter Creevy Model 01267524Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741018824), received between Feb 12, 2018 and Jan 21, 2025 — classified as 1 injury, 13 malfunctions.

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

• MalfunctionJan 21, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT BEFORE USE, THE FOLEY CATHETER BALLOON COULD NOT BE DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197172 ↗
• MalfunctionAug 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE BALLOON AT THE FRONT END OF THE CATHETER WAS BROKEN AND LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20048704 ↗
• MalfunctionNov 22, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE NURSE TESTED THE FOLEY CATHETER BEFORE USE. THEY PUSHED THE NORMAL SALINE 60CC AND THE FOLEY CATHETER BALLOON SUDDEN RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191919 ↗
• MalfunctionMar 12, 2023Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON COULD NOT BE INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527266 ↗
• InjuryApr 18, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT BACTERIURIA WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE BARD 2-WAY 60CC STRAIGHT TIPPED HYDROGEL COATED PROSTATIC CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 14135140 ↗
• MalfunctionMar 4, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT BEFORE UNPACKING, IT WAS FOUND THAT THERE WAS NO FOLEY CATHETER WATER BALLOON CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666866 ↗
• MalfunctionNov 9, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT INFLATE AFTER THE CATHETER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12782917 ↗
• MalfunctionOct 19, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON COULD NOT BE DEFLATED. THE CUSTOMER HAD TO CHANGE TO A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657342 ↗
• MalfunctionOct 19, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON COULD NOT BE DEFLATED. THE CUSTOMER HAD TO CHANGE TO A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656810 ↗
• MalfunctionSep 17, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON COULD NOT BE DEFLATED, HENCE THE CUSTOMER CHANGED TO A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488005 ↗
• MalfunctionAug 30, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE WATER COULD NOT BE INJECTED INTO THE FOLEY CATHETER BALLOON AND SUSPECTED THAT THE WATER INJECTION PIPELINE WAS BLOCKED SO THE CUSTOMER CHANGED TO A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389412 ↗
• MalfunctionJun 11, 2018Inflation Problem; Inability to Irrigate; Difficult to Remove; Aspiration Issue; Difficult to Remove

  IT WAS REPORTED THAT AFTER THE BALLOON WAS INFLATED, WATER COULD NOT BE WITHDRAWN FROM THE BALLOON. PER ADDITIONAL INFORMATION RECEIVED: ASPIRATING THE WATER THROUGH IRRIGATION SITE WAS NOT SMOOTH.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7589346 ↗
• MalfunctionFeb 12, 2018Inability to Irrigate; Device Operates Differently Than Expected; Inability to Irrigate

  IT WAS REPORTED THAT THE CATHETER DID NOT FLUSH SMOOTHLY DURING IRRIGATION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7263354 ↗
• MalfunctionFeb 12, 2018Flushing Problem; Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT THE CATHETER DID NOT FLUSH SMOOTHLY DURING IRRIGATION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7263323 ↗