Bard® Flip-Flo™ Catheter Valve BFF5Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741131776), received between Jul 24, 2018 and Aug 12, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (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, 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryOct 4, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE FLIP-FLO VALVE WAS BEING USED WITH A COLOPLAST INDWELLING CATHETER AND THE VALVE KEPT SLIPPING FROM THE CATHETER CAUSING SPILLS. ONE SPILL RECENTLY RESULTED IN THE PATIENT SLIPPING. THE PATIENT EXPERIENCED A HEAD INJURY REQUIRING A BLOOD TRANSFUSION AND THREE HOURS OF PLASTIC SURGERY. PATIENT HAS BEEN USING THIS PRODUCT SINCE DECEMBER OF 2020 AND WOULD LIKE TO KNOW IF ANYTHING HAS CHANGED. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 16SEP2021 FROM THE COMPLAINANT, THEY HAD PREVIOUSLY USED A NIGHT DRAINAGE BAG WHICH HAD EFFECTIVE GROOVE LINES AROUND IT THAT WAS NOT FEATURED ON THE BARD FLIP FLO VALVE. THIS TYPE OF CONNECTION DID NOT COME UNDONE EVEN DURING SLEEP OR WHEN THE PATIENT TWIST AND TURNED A LOT. SHE THOUGHT THESE SIMPLE GROOVES ON THE CONNECTOR WAS SOMETHING BD SHOULD CONSIDER PROTOTYPING OR TRIALING ON THE HARD PLASTIC CONNECTOR PART OF THE FLIP FLO VALVE AS THIS WAS WHERE THE PROBLEMS HAVE OCCURRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Brain Injury; Head Injury; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12571746 ↗
• MalfunctionJul 24, 2018Inadequate Instructions for Healthcare Professional; Manufacturing, Packaging or Shipping Problem; Inadequate Instructions for Healthcare Professional

  IT WAS REPORTED THAT 2 BOXES (5 IN EACH) OF THE BFF5 CONTAINED BFF20.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 7715234 ↗