Bardex® Lubricath® Foley Catheter Councill Model 0196L20Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741017940), received between Jan 10, 2018 and Jul 31, 2026 — classified as 9 malfunctions.

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

• MalfunctionJul 31, 2026Nonstandard Device; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100483 ↗
• MalfunctionSep 11, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED INTO THE PATIENT, THE BALLOON WAS INFLATED, HOWEVER THE CATHETER DID NOT STAY IN THE PATIENT, IT FELL OUT. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 23SEP2025, CUSTOMER WAS STILL WAITING FOR THE BOX. THEY HAVE ONE DRAIN THAT WAS USED ON THE PATIENT, AND THE REST IN ITS BOX WITH THE SAME LOT NUMBER. CUSTOMER CANNOT GIVE OUT ANY MEDICAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23030868 ↗
• MalfunctionJul 7, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER USED THIS PARTICULAR CATHETER ON THREE DIFFERENT PATIENTS, AND EACH ONE HAD A BALLOON FAILURE. HE INSERTED THE CATHETER INTO THE PATIENT, BLEW UP THE BALLOON, AND THE BALLON FAILED, HAVING THE CATHETER FALL OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412739 ↗
• MalfunctionJul 2, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ONE OF THE SURGEONS WENT TO BLOW THE BALLOON AND IT MALFUNCTIONED AND FELL OFF THE PT. THIS ISSUE OCCURRED ON A TOTAL OF 3 INSTANCES ON DIFFERENT PATIENT. DOE FOR ONE OF THE EVENTS (B)(6), OTHER DATES NOT AVAILABLE. 1 SAMPLE AVAILABLE FOR RETURN REF: (B)(4), LOT NGHS088.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383972 ↗
• MalfunctionJun 30, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ONE OF THE SURGEONS WENT TO BLOW THE BALLOON AND IT MALFUNCTIONED AND FELL OFF THE PT. THIS ISSUE OCCURRED ON A TOTAL OF 3 INSTANCES ON DIFFERENT PATIENT. DOE FOR ONE OF THE EVENTS (B)(6) , OTHER DATES NOT AVAILABLE. 1 SAMPLE AVAILABLE FOR RETURN REF: (B)(4) , LOT NGHS088.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357843 ↗
• MalfunctionAug 28, 2020Leak/Splash; Material Deformation; Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT THE CATHETER WAS DEFORMED AFTER THE FIRST MONTH OF USE. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 25AUG2020, THE PATIENT IS BEDRIDDEN AD HAS BEEN PARALYZED SINCE 2014. THE CATHETER WAS PLACED TRANSURETHRALLY. NACL 0.9% LIQUID WAS SUCCESSIVELY INSERTED STARTING WITH 10, 15, 20 AND 25 FILLINGS; AN ATTEMPT WAS MADE TO HUMIDIFY THE CATHETER TIP FOR 5 MINUTES IN NACL WHICH HAS BEEN SUCCESSFULLY DONE WITH THE PORTUGUESE ONES. IN SPITE OF THIS, BEHAVIOR WAS THE SAME EVEN AFTER 1 MONTH ALL CATHETERS BEGINS TO LEAK. REGULAR CATHETER IRRIGATION WAS PERFORMED AND THE PATIENT WAS ABLE TO BE RE-CATHETERIZED. NO SUTURES WERE USED TO ANCHOR THE CATHETER IN THE PATIENT. THERE WERE NO MISSING PIECES. PER NOTIFICATION RECEIVED VIA INVESTIGATOR ON 21OCT2020, AS THE DEVICE WAS NOT INTENDED TO BE USED WITH SALINE.

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

  MAUDE report 10469256 ↗
• MalfunctionJan 3, 2020Deflation Problem; Deflation Problem; Device Slipped

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT WHEN THEY ATTEMPTED TO SIT DOWN. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9544701 ↗
• MalfunctionAug 27, 2018Deflation Problem; Device Fell

  IT WAS REPORTED THAT THE BALLOON DEFLATED AND FELL OUT OF THE PATIENT IMMEDIATELY AFTER INSERTION.

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

  MAUDE report 7817300 ↗
• MalfunctionJan 10, 2018Deflation Problem

  IT WAS REPORTED THAT THE CATHETER FELL OUT OF THE PATIENT ON THE FOURTH DAY OF USE. THE BALLOON WAS DEFLATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7177968 ↗