Bard® Flip-Flo™ Catheter Valve BFF20Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741131783), received between Jan 4, 2019 and Sep 14, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Component Missing” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Fracture

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 50765286 ↗
• MalfunctionJun 25, 2026Complete Blockage; Difficult to Open or Close

  IT WAS REPORTED THAT HEALTH PROFESSIONAL HAD BEEN RECEIVING A SIGNIFICANT NUMBER OF COMPLAINTS FROM OUR UROLOGY DEPARTMENT OVER THE PAST MONTH REGARDING THE FLIPFLO VALVES. THE VALVES FREQUENTLY BECOME BLOCKED, CAUSING THE LEVER TO BREAK OR BEND DURING HANDLING. AS A RESULT, OUTPATIENT PATIENTS OFTEN NEED TO RETURN MULTIPLE TIMES FOR A REPLACEMENT VALVE. ATTACHED, YOU WILL FIND A PHOTO OF A DEFECTIVE VALVE ALONG WITH THE CORRESPONDING LOT NUMBER. WE HAVE NOT ENCOUNTERED THESE ISSUES IN THE PAST. REPLACEMENT TO BE DISCUSSED WITH THE CUSTOMER - PLEASE REACH OUT TO THE RESPONSIBLE AM LIEVE VIVIER FOR THIS (CURRENTLY ON VACATION UNTIL JUNE 28TH) PLEASE ALSO VERIFY OTHER REPORTED COMPLAINTS, BY OTHER CUSTOMERS OR OTHER COUNTRIES AND SHARE YOUR FEEDBACK. INCREASED COMPLAINTS ABOUT FLIPFLO VALVES OVER THE PAST MONTH DUE TO FREQUENT BLOCKAGE AND BREAKAGE OF THE LEVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630815 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTION (UTI) PRIOR TO THE DEVICE PLACEMENT AND SYMPTOMATIC URINARY TRACT INFECTION (UTI) COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE OCCURRED 4 DAYS AFTER THE DEVICE PLACEMENT AND NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED IN RELATION TO BFF20 - FLIP-FLO CATHETER VALVE WITH 180° LEVER TAP. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 17624102 ↗
• MalfunctionJul 28, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT NO, THEY WERE NOT ABLE TO SUCCESSFULLY USE THE DEVICE FOR URINE DRAINAGE BECAUSE IT HAD TROUBLE DRAINING THE URINE IN RELATION TO BFF20 ¿ FLIP-FLO CATHETER VALVE WITH 180° LEVER TAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17418891 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN AN ONLINE SURVEY A PHYSICIAN STATED THAT THE PATIENT EXPERIENCED UTI (URINARY TRACT INFECTION) PRIOR TO THE DEVICE PLACEMENT AND 15 DAYS AFTER THE DEVICE PLACEMENT NON-SYMPTOMATIC UTI COMPLICATIONS WERE DIRECTLY ATTRIBUTABLE TO THE DEVICE, AND PLACEMENT OF WIRED CATHETER WAS NEEDED IN RELATION TO BFF20 ¿ FLIP-FLO CATHETER VALVE WITH 180° LEVER TAP. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 17349446 ↗
• MalfunctionFeb 25, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE FLIP FLO CATHETER VALVE PACKAGE WAS EMPTY, ALTHOUGH THE PACKAGE WAS PERFECTLY SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599999 ↗
• InjuryOct 12, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT SAID THE FLIP FLO VALVE CAUSED INFECTIONS BECAUSE IT WAS TOO DIFFICULT TO CLEAN. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INFECTION. PER FOLLOW-UP VIA PHONE ON 01NOV2021, STATED THAT PATIENT HAD TO USE THE CATHETER LONGER THAN THEY SHOULD. PATIENT HAD OUT OF SUPPLIES BECAUSE LIBERATOR WAS UNABLE TO SEND THE ONES, THEY NEEDED TIMELY. ALSO STATED THAT LIBERATOR WAS NOT BEING SENT THE CORRECT CATHETER THEY NEEDED. PATIENT NEED AN INFECTION CONTROL CATHETER BECAUSE OF URINARY TRACT INFECTION WITH USE OF THESE CATHETERS. HENCE, THERE WAS NO INFECTION CONTROL COATING ON THEM. PATIENT HAD PRESCRIBED ANTIBIOTICS FOR THE URINARY TRACT INFECTION. MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 12616262 ↗
• MalfunctionFeb 13, 2020Component Missing; Packaging Problem; Component Missing

  IT WAS REPORTED THAT THE PACKAGE WAS FOUND EMPTY. THERE WAS NO FLIP-FLO IN THE PACKAGE.

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

  MAUDE report 9706677 ↗
• MalfunctionJan 4, 2019Fluid/Blood Leak; Material Twisted/Bent

  IT WAS REPORTED THAT VALVE WAS BENT AND AS A RESULT CAUSED LEAKING. PRODUCT WAS REPLACED. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8216718 ↗