Bardia® Foley Catheter Silicone Coated 123520ARecalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 00801741095115), received between Aug 23, 2017 and Aug 7, 2026 — classified as 7 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (13 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 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Deflation Problem

  It was reported that during use the foley catheter balloon cannot be removed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50181185 ↗
• MalfunctionJul 30, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50092627 ↗
• MalfunctionOct 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT ON (B)(6) 2025 AN INDWELLING URINARY FOLEY CATHETER WAS INSERTED PER PHYSICIAN'S ORDERS. THE PROCEDURE PROCEEDED SMOOTHLY, WITH THE CATHETER SECURELY FIXED AND URINE DRAINING FREELY. AT 5:20 ON (B)(6) 2025 THE ON-DUTY NURSE DISCOVERED THE CATHETER HAD BECOME DISLODGED WHILE ASSISTING THE PATIENT WITH REPOSITIONING. EXAMINATION REVEALED THE WATER BALLOON HAD RUPTURED, CAUSING FIXATION FAILURE. THE CATHETER WAS PROMPTLY REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323735 ↗
• MalfunctionAug 19, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840493 ↗
• MalfunctionJul 31, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675995 ↗
• MalfunctionMay 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE A FEW DAYS AFTER PLACEMENT, THE FOLEY CATHETER BALLOON WAS BROKEN AND WAS REMOVED SPONTANEOUSLY. THEY HAD NOT RECEIVED ANY REPORTS OF ANYTHING BEING LEFT INSIDE THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089400 ↗
• MalfunctionJan 8, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PORT WAS USED TO INFLATE THE BALLOON NOT WORKING. BALLOON WOULD NOT INFLATE IN THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102440 ↗
• MalfunctionOct 14, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS BALLOON LEAK FROM THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438719 ↗
• MalfunctionAug 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE URINARY FOLEY CATHETER HAD BEEN INSERTED INTO THE PATIENT AND SLIPPED OUT OF THE BODY AND THE WATER BAG WAS FOUND TO BE RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20004676 ↗
• MalfunctionApr 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAKAGE FROM THE FOLEY CATHETER AND THE WATER BALLOON WAS UNEVEN. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 20MAR2024, NO SERIOUS INJURY OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031203 ↗
• MalfunctionOct 11, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS BLOCKED AND WOULD NOT FLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912550 ↗
• MalfunctionSep 13, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON WAS RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17736022 ↗
• MalfunctionAug 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LAST ORDER THE PATIENT HAD A BAD FOLEY CATHETER IT STARTED TO LEAK WHEN THEY WAS OUT ONE DAY HAD TO USE NEW CATHETER WHEN THEY GOT. IT WAS STATED THAT THE PATIENT TOLD THE REPRESENTATIVE ABOUT IT WHEN THEY PLACED THE NEW ORDER THAT THEY WOULD BE SHORT AND NEED 4 NOT 3 FOLEY ALSO ADVISED PATIENT THAT COULD ONLY PLAY THREE FOLEYS ON 90 DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563668 ↗
• MalfunctionMay 23, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEAKING. PER FOLLOW UP VIA PHONE ON 05MAY2023, IT WAS REPORTED CUSTOMER WERE CURRENTLY GETTING THEIR SUPPLIES THROUGH ADAPTHEALTH AND THE FOLEY CATHETER BALLOON DEFLATED CONSTANTLY WHICH MAKES IT DIFFICULT TO COLLECT ANY URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16983871 ↗
• MalfunctionMay 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEAKING. PER FOLLOW UP VIA PHONE ON 05MAY2023, IT WAS REPORTED CUSTOMER WERE CURRENTLY GETTING THEIR SUPPLIES THROUGH ADAPTHEALTH. THE BALLOON DEFLATED ON THE CATHETER CONSTANTLY WHICH MAKES IT DIFFICULT TO COLLECT ANY URINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973271 ↗
• MalfunctionFeb 24, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WATER IN THE FOLEY CATHETER BALLOON COULD NOT ESCAPE. THE BALLOON WAS CUT OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436702 ↗
• MalfunctionOct 27, 2022Calcified; Material Fragmentation; Calcified; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS REMOVED TODAY DUE TO A PATIENT REPORT OF LEAKING. THE CATHETER WAS DUE TO BE CHANGED ON OR AROUND (B)(6) 2022. THEREFORE, THE PATIENT REQUESTED A NEW CATHETER TO BE INSERTED. UPON REMOVAL OF THE OLD CATHETER, A SUBSTANCE PALE YELLOW IN COLOR LANDED ON THE PATIENT'S VULVA. UPON INSPECTION, THE MATERIAL WAS HARD AND NON-PALPABLE. WHEN SQUEEZED, IT BROKE INTO 3 PIECES, AND THE CLINICIAN CLOSELY EXAMINED THE TIP AND DEFLATED BALLOON OF THE CATHETER. UPON VISUAL AND TACTILE INSPECTION, THE CLINICIAN NOTED THAT WHEN THE TIP OF THE CATHETER WAS SQUEEZED OR LIGHTLY SCRAPED WITH A GLOVED FINGER, PARTICLES WERE DISLODGING FROM THE CATHETER AND APPEARED TO BE CATHETER MATERIAL DISLODGING FROM THE CATHETER . NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15680978 ↗
• MalfunctionSep 27, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON HAD TO BE REFILLED FREQUENTLY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494153 ↗
• MalfunctionJun 22, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BURST WHILE TRYING TO INFLATE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14778413 ↗
• MalfunctionMay 16, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT FILL UP WITH WATER CORRECTLY AND IT SPILLED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14408252 ↗
• MalfunctionMay 10, 2022Collapse; Nonstandard Device; Collapse; Nonstandard Device

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE RIGID WHEN COMPARED TO THE OLD PRODUCT. BD REPRESENTATIVE DISCUSSED WITH NURSING STAFF THAT THIS WAS PREFERABLE AND IT WOULD CAUSE LESS DAMAGE BECAUSE IT MADE IT EASIER TO INSERT AND PROBABLY PROMOTES BETTER DRAINAGE. REPRESENTATIVE WAS GUESSING ABOUT THE OLD PRODUCT THAT WAS COLLAPSING ON ITSELF WHICH WAS A PART OF THE ISSUE BEFORE. NURSE AGREED BUT SAID THAT SOME HAVE NOTICED A DROP OF BLOOD. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW-UP VIA PHONE ON 22APR2022, CUSTOMER FELT LIKE IT WAS THE END USER ERROR AND NOT THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14348065 ↗
• InjuryMay 10, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT HAD TO GO TO THE EMERGENCY ROOM ON (B)(6) 2022 WITH THIS ORDER SINCE THE FOLEY CATHETER WAS NOT DRAINING THE URINE INTO THE LEG BAG AND WENT ALL AROUND THE PENIS.

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

  MAUDE report 14345372 ↗
• MalfunctionMay 6, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT HAD TO GO TO THE EMERGENCY ROOM ON APR 3 AND APR 13 WITH THIS ORDER SINCE THE FOLEY CATHETER WAS NOT DRAINING THE URINE INTO THE LEG BAG AND WENT ALL AROUND THE PENIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14304740 ↗
• MalfunctionApr 25, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE FOLEY CATHETERS DID NOT COME WITH THE SYRINGE TO USE. IT WAS ALSO STATED THAT IT SHOULD HAD IT BECAUSE THE CATHETER COULD NOT BE INFLATED WITHOUT THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14194097 ↗
• MalfunctionMar 17, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHEN THE FOLEY CATHETER WAS REMOVED, THE BALLOON WAS NOT SMOOTH AND COULD NOT BE COMPLETELY ELIMINATED. IT WAS STATED THAT THERE WAS STILL 1 TO 2ML IN THE BALLOON. IT WAS MENTIONED THAT THE CUSTOMER CUT OFF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13795636 ↗