Bard Flip-Flo Catheter ValveRecalls & reported problems across all models

We found 2 models of Bard Flip-Flo Catheter Valve by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Jul 24, 2018 and Sep 14, 2026 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Component Missing” (3 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 Bard Flip-Flo Catheter Valve problems

Bard Flip-Flo Catheter Valve models

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

• Bard® Flip-Flo™ Catheter Valve BFF5

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  12 reports
• Bard® Flip-Flo™ Catheter Valve BFF20

  COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
  9 reports

Recent Bard Flip-Flo Catheter Valve adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionAug 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE FLIP FLOW CATHETER VALVE HAD CRACKS IN THE HUB THAT WAS INSERTED INTO THE CATHETER AND PICTURE IN THE ATTACHMENT WITH BATCH NGJW3053. DUE TO THE VALUE OF THE PRODUCT, THE CUSTOMER WOULD PREFER NOT TO REQUEST A CREDIT NOTE OR SIMILAR FOR THIS, BUT WANTED TO REPORT IT IN CASE THIS WAS A MANUFACTURING DEFECT IN THIS BATCH. CRACKS IN THE HUB THAT IS INSERTED INTO THE CATHETER (SEE PICTURE IN THE ATTACHMENT). BATCH: NGJW3053.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781994 ↗
• MalfunctionJul 2, 2025Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE SOMETIMES WHEN USING THE FLIP FLOW CATHETER VALVES THE URINE WAS TRICKLING OUT AND NOT FLOWING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384682 ↗
• MalfunctionMar 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT A BATCH OF BARD FLIP FLOW CATHETER VALVE, THAT HAD CRACKS IN THEM. THEY WERE RETURNED BY A PATIENT AS WHEN PATIENT HAD BEEN USING, THEY HAVE HAD LEAKED, AND PATIENT HAD NOTICED THESE CRACKS. 2 BOXES OF BATCH NGJU3636 WHERE ALL THE TAPS WERE AFFECTED. PATIENT WAS EXPOSED TO HAZARDOUS, BLOOD, OR BODILY FLUIDS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Exposure to Body Fluids

  MAUDE report 21721835 ↗
• MalfunctionMar 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CUSTOMER COULD NOT CONNECT THE FLIP-FLO TO AN OVERNIGHT BAG OR A LEG BAG. IT WAS STATED THAT THE CUSTOMER HAD BIG ISSUE WAS WITH THE NIGHT BAG AND CONNECTION TO THE FLIP-FLO VALVE COULD BEND AND BLOCK OFF THEIR BLADDER COMPLETELY AND IT DID NOT ALLOW VOIDING/EMPTYING PROPERLY, ALSO STATED THAT CUSTOMER WAS HAVING TO TAPED IT TO ENSURE IT STAY ON AND STIFF. THE REPRESENTATIVE DID OFFER THE SOLUTION OF REMOVING THE FLIP-FLO VALVE AND CONNECTING DIRECTLY TO THE DRAINAGE, BUT THEY STATED IT WOULD STILL NOT FIX THE ISSUE WITH THE VALVE BENDING OVERALL. PER FOLLOW UP VIA PHONE ON 15FEB2025, IT WAS REPORTED THAT THE CUSTOMER PROVIDED SUGGESTIONS ON HOW TO MAKE THE DRAIN BAGS BETTER WITH THE FLIP FLO VALVES. OFFERED TO SEND IN A DRAWING ON HOW TO MAKE THEY BETTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698683 ↗
• MalfunctionMar 14, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PRODUCT BARD FLIP-FLO CATHETER VALVE BXBFF5 WITH LOT NUMBER NGHZ1048 AND EXPIRATION DATE (B)(6) 2028, HAD REGULAR PROBLEMS AS THEY DO NOT GO THE WAY THEY ARE SUPPOSED TO GO, THEY ARE STIFF HARD TO GET CLOSED AFTER 1 OR 2 WEEKS. ALSO, THEY BROUGHT IT UP WITH THE UROLOGY NURSE THEY WERE AWARE. IT WAS GETTING EXPENSIVE AS THE PATIENT NEEDED 2 OR 3 IN 6 WEEKS. AMONG WHICH ONE ALREADY BROKEN OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21605301 ↗
• MalfunctionAug 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PREVIOUS DAY THE PATIENT HAD CHANGED THE FLIP FLOW VALVE. WOKE UP TO WET SHEETS ETC. AS THE VALVE WAS LEAKING FROM THE TURNING POINT, IT WAS IN THE CLOSED POSITION ALL NIGHT, X1 AFFECTED OUT OF X5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075138 ↗
• MalfunctionApr 24, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE FLIP FLOW CATHETER VALVE WAS FAULTY. IT WOULD NOT WORK. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 01APR2024, URINE WOULD NOT FLOW THROUGH, AND URINE WAS NOT FLOWING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19171979 ↗
• 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 ↗
• MalfunctionJun 15, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE NURSE COMPLAINED THAT THE FOLEY CATHETER SLIPPED OUT AUTOMATICALLY. THE NURSE WENT TO THE BEDSIDE TO CHECK AND FOUND THAT THE BLADDER OF THE FOLEY CATHETER WAS DEFLATED, AND CHECKED THAT THE PATIENT'S URETHRAL OPENING WAS NOT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17133864 ↗
• MalfunctionMay 11, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE PATIENT RECEIVED 5 BFF5 BUT 2 OF THE BOXES WERE EMPTY. ALL 5 BOXES WERE SEALED, BUT PATIENT ONLY RECEIVED 3 VALVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911225 ↗
• MalfunctionApr 4, 2023Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT THE CUSTOMER HAD BROUGHT SOME FLIP FLOW CATHETER VALVES AND STATED THAT THEY WERE NOT DRAINING PATIENT'S BLADDER UNLESS ATTACHED TO A BAG. STATED THAT THEY HAD PROBLEMS WITH THEIR CURRENT CATHETER VALVES AS IT WAS NOT EMPTYING UNLESS ATTACHED TO A LEG OR NIGHT BAG. WHEN THE TAP WAS OPENED, THERE WAS NO FLOW BUT, AS SOON AS THEY ATTACHED IT TO A BAG, THEIR BLADDER EMPTIED. STATED THAT THEY PREVIOUSLY HAD VALVES WHICH WOULD EMPTY THEIR BLADDER VIA THE CATHETER DIRECTLY JUST BY TURNING THE LEVER. THE CUSTOMER ASKED WHETHER THERE WAS SOMETHING WRONG WITH THE VALVE OR WAS THERE ANOTHER POSSIBLE REASON FOR THIS. THE CUSTOMER HAD TRIED SEVERAL WITH THE SAME RESULT. THE REPRESENTATIVE GAVE THEM THE NURSE ADVICE LINE AND ADVISED THAT THEY MIGHT BE ABLE TO HELP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675158 ↗

Other C. R. Bard, Inc. products

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• Bardex All-Silicone Foley Catheter12 models · 1,170 reports