Bard® Lubricath® Foley Catheter 365718Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741077753), received between Sep 26, 2017 and Nov 6, 2023 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON BROKE AT HOME. THE PATIENT HAD TO RETURN TO CLINIC WITH FOLEY ALREADY OUT AND HAD ANOTHER ONE INSERTED. NO APPARENT HARM DONE BUT AN INCONVENIENCE AND DISCOMFORT FOR THE PATIENT TO HAVE TO HAVE ANOTHER FOLEY CATHETER INSERTED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074550 ↗
• InjuryApr 6, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS UNABLE TO BE DEFLATED PRIOR TO VAGINAL DELIVERY. ATTEMPTED TO REMOVE BY CUTTING THE FOLEY WHICH WAS PERFORMED AFTER THE INABILITY TO RELEASE THE BALLOON, BUT WAS UNSUCCESSFUL. IT WAS STATED THAT THE BALLOON WAS EVENTUALLY RELEASED USING TRANSVAGINAL RELEASE WITH SPINAL NEEDLE PER UROLOGY RECOMMENDATIONS. MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 14021940 ↗
• MalfunctionDec 5, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON RUPTURED, PROBABLY BY IRRIGATING IT IN THE WRONG WAY AS TOLD BY THE CUSTOMER. ( LOT NO: MYEU4754), (LOT NO:MYFN3541).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931178 ↗
• MalfunctionSep 20, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A 18FR FOLEY CATHETER WAS PLACED IN THE EMERGENCY DEPARTMENT AND IT WAS REMOVED BY THE UROLOGY THREE DAYS LATER IN MEDICAL INTENSIVE CARE UNIT. IT WAS STATED THAT WHEN THEY ATTEMPTED TO EMPTY THE FOLEY BALLOON WITH AN EMPTY SYRINGE, THEY WERE ONLY ABLE TO GET 4 ML OUT AND THE CATHETER WAS COLLAPSING, IT WAS UNABLE TO REMOVE ANYMORE. IT WAS REPORTED THAT THEY WERE UNABLE TO PULL FOLEY DUE TO RESISTANCE AND THE PATIENT COMPLAINED OF PAIN AND THE UROLOGY HAD TO REMOVE AT BEDSIDE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 12494842 ↗
• MalfunctionFeb 27, 2020Burst Container or Vessel; Fluid/Blood Leak; Material Puncture/Hole; Device Fell; Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER WAS INSPECTED AND FOUND TO HAVE A HOLE ON THE BALLOON WHICH ALLEGEDLY CAUSED FLUIDS TO LEAK OUT AND THE CATHETER TO FALL OUT OF THE PATIENT.

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

  MAUDE report 9763989 ↗
• InjuryNov 7, 2019Deflation Problem

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER WOULD NOT DEFLATE. THE COMPLAINANT REPORTED THAT THEY ATTEMPTED TO SIPHON THE FLUID FROM THE BALLOON PORT BUT WAS UNSUCCESSFUL. THE BALLOON PORT WAS REPORTEDLY THEN COMPLETELY CUT WITH A PAIR OF SCISSORS BUT THE BALLOON DID NOT DEFLATE. THE COMPLAINANT REPORTED THAT A WIRE WAS PASSED UP THROUGH THE BALLOON PORT BUT THE BALLOON STILL WOULD NOT DEFLATE. A SYRINGE WAS THEN CONNECTED TO THE URINE DRAIN PORT OF THE CATHETER AND PULLED BACK, THE FLUID THEN STARTED TO DRIP FROM THE BALLOON PORT AND THE BALLOON ULTIMATELY DEFLATED.

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

  MAUDE report 9293389 ↗
• MalfunctionNov 7, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS DIFFICULT TO DEFLATE. THE COMPLAINANT REPORTED THAT THE DRAIN BAG WAS THEN DISCONNECTED AND A SYRINGE ATTACHED AND THE FLUID WAS THEN REMOVED FROM THE BALLOON ONE CC AT A TIME UNTIL IT WAS COMPLETELY DEFLATED.

  Patient problems: Discomfort

  MAUDE report 9293286 ↗
• MalfunctionNov 4, 2019Deflation Problem; Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON ON THE FOLEY CATHETER WOULD NOT DEFLATE WITH THE SYRINGE. THE COMPLAINANT REPORTED THAT THEY ENDED UP CUTTING THE TIP OFF FOR THE BALLOON TO DEFLATE.

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

  MAUDE report 9271998 ↗
• MalfunctionApr 23, 2019Deflation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON PREMATURELY DEFLATED AND AS A RESULT FELL OUT OF THE PATIENT. THIS RESULTED IN MULTIPLE CATHETER CHANGES.

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

  MAUDE report 8542094 ↗
• MalfunctionJan 23, 2019Material Invagination; Malposition of Device; Material Invagination

  IT WAS REPORTED THAT THE BALLOON OF THE HYDROGEL FOLEY CATHETER WAS OFF CENTER WHEN INFLATED DURING PRE-TESTING.

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

  MAUDE report 8271861 ↗
• MalfunctionJan 22, 2019Nonstandard Device; Positioning Problem; Nonstandard Device

  IT WAS REPORTED THAT THE BALLOON OF THE HYDROGEL FOLEY CATHETER WAS OFF CENTER WHEN INFLATED DURING PRE-TESTING.

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

  MAUDE report 8268813 ↗
• MalfunctionNov 15, 2018Burst Container or Vessel; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BALLOON WAS INFLATED WITH 10CC OF WATER AND THEN IMMEDIATELY BURST INSIDE OF A PATIENT WITH NO MISSING PIECES. THE CUSTOMER WOULD LIKE THE OUTER PACKAGING OF ALL THE FR SIZES TO STATE THE CORRECT BALLOON SIZE INSTEAD OF 5CC FOR A 10CC CATHETER.

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

  MAUDE report 8073877 ↗
• MalfunctionAug 8, 2018Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CATHETER WAS INSERTED ON (B)(6) 2018 AND A SCAN SHOWED THAT THE PATIENT RETAINED OVER 500 CC. UPON INSERTION OF THE CATHETER, 550 CC WAS DRAINED FROM THE PATIENT'S BLADDER. IT WAS LATER NOTED THAT THERE WAS NOT ANY OUTPUT. THE FOLEY WAS MANIPULATED AND 350CC OF URINE DRAINED INTO THE DRAINAGE BAG.

  Patient problems: Urinary Retention

  MAUDE report 7764180 ↗
• MalfunctionMar 7, 2018Material Rupture

  IT WAS REPORTED THAT SOMETIME IN (B)(6) 2017, A (B)(6), BED RIDDEN, FEMALE PATIENT HAD A FOLEY CATHETER PLACED FOR URINE DRAINAGE DUE TO URINARY INCONTINENCE. AFTER A COUPLE OF WEEKS OF THE CATHETER BEING PLACED, IT WAS NOTICED BY THE FAMILY THAT THE CATHETER WAS LEAKING. THE HOME HEALTH NURSE WAS NOTIFIED, WHO CAME OVER AND CHECKED THE BALLOON ON THE CATHETER AND INFLATED THE BALLOON MORE. LATER THAT SAME DAY, THE CATHETER STARTED LEAKING AGAIN AND CAME OUT OF THE PATIENT. SEVERAL ATTEMPTS WERE MADE BY THE HOME HEALTH NURSE TO INSERT ANOTHER CATHETER, BUT WERE UNSUCCESSFUL. THE FAMILY MADE ARRANGEMENTS TO HAVE THE PATIENT TRANSFERRED TO THE EMERGENCY ROOM AT THE HOSPITAL. AFTER ARRIVING AT THE HOSPITAL, A CATHETER WAS INSERTED INTO THE PATIENT WITHIN 10 MINUTES. THE PATIENT WAS KEPT FOR OBSERVATION AND DISCHARGED THE FOLLOWING MORNING. ALSO, IT WAS MENTIONED BY THE PATIENT¿S SON THAT HIS MOTHER PASSED AT HOME ON (B)(6) 2018, WHICH WAS SEVERAL WEEKS AFTER SHE WAS DISCHARGED FROM THE HOSPITAL. THE SON STATED THAT HIS MOTHER DIED DUE TO HER CHRONIC MEDICAL CONDITIONS. THE PATIENT¿S DEATH WAS NOT RELATED TO THE DEVICE. SHE HAD A HISTORY OF PARKINSON¿S, WAS VISUALLY IMPAIRED AND HAD A

  Patient problems: Death

  MAUDE report 7321471 ↗
• MalfunctionFeb 21, 2018Leak/Splash

  IT WAS REPORTED THAT THE CATHETERS WERE LEAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7287896 ↗
• MalfunctionFeb 3, 2018Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVE DUE TO THE BALLOON NOT DEFLATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7239949 ↗
• InjuryNov 16, 2017Material Rupture

  IT WAS REPORTED THAT THE BALLOON OF THE CATHETER BURST WITHIN THE PATIENT AND PIECES WERE MISSING. A CYSTOSCOPY WAS PERFORMED TO RETRIEVE THE PIECES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036616 ↗
• MalfunctionSep 26, 2017Hole In Material

  IT WAS REPORTED THAT THE CATHETER HAD A HOLE IN IT. COMPLAINANT STATED THAT THEY WERE UNAWARE OF WHERE THE HOLE WAS LOCATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6893438 ↗