Bard® Lubricath® Foley Catheter 365714Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741077739), received between Oct 5, 2017 and Jan 30, 2026 — classified as 8 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (18 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2026Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON POPPED INSIDE PATIENT. PER FOLLOW UP INFORMATION RECEIVED ON 20FEB2026, IT WAS REPORTED PATIENT DID REQUIRE ANOTHER CATHETER INSERTION, OTHERWISE NO OTHER MEDICAL INTERVENTION REQUIRED. NO TROUBLESHOOTING WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226378 ↗
• MalfunctionJan 30, 2026Material Rupture

  IT WAS REPORTED THAT A CATHETER INSERTED IN THE EMERGENCY DEPARTMENT MALFUNCTIONED. NURSING STAFF NOTED THAT THE FOLEY CATHETER WAS BYPASSING DURING THE DAY AND NIGHT. THE PATIENT REPORTED FEELING A ¿POP,¿ AFTER WHICH THE CATHETER SLIPPED OUT, AND THE BALLOON APPEARED VISIBLY BROKEN. THE CATHETER WAS PART OF A KIT/TRAY. NO HARM OCCURRED TO THE PATIENT. PHOTOS WERE TAKEN OF THE CATHETER, WITH TUBING NUMBERS 365714 AND 50N096 DOCUMENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221909 ↗
• MalfunctionOct 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THREE OF THE PATIENT'S CATHETERS HAD BURST. THEY HAD PRODUCT TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438726 ↗
• MalfunctionApr 5, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE 10CC FLUID COULD NOT BE DRAINED FROM THE FOLEY BALLOON. PER ADDITIONAL INFORMATION RECEIVED ON 02APR2024, IT WAS REPORTED THAT THERE WAS NO RESISTANCE WHILE INFLATING THE BALLOON AND THE USER WAS UNABLE TO REMOVE THE STERILE WATER AFTER INSTILLING INTO THE BALLOON WITH THE PROVIDED SYRINGE OR ANY OTHER SYRINGE. IT WAS INITIALLY DISCOVERED DURING THE BALLOON CHECK PRIOR TO USE ON PATIENT, NO CONTACT WAS MADE WITH THE FOLEY ON THE PATIENT. ON A COUPLE OCCASIONS, MULTIPLE KITS FAILED, THEY ONLY KEPT ONE FOLEY FROM THAT LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051091 ↗
• MalfunctionApr 2, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT DEFLATE DURING A PRETEST PRIOR TO INSERTION. THIS WAS THE THIRD EVENT IN THE LAST 2 MONTHS AND THEY COULD ONLY SAVE THIS SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19018374 ↗
• MalfunctionFeb 21, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT NURSE INSERTED 14F FOLEY CATHETER AND INFLATED BALLOON WITH ONLY 5ML OF STERILE WATER AND ATTACHED FOLEY TO CATHETER BAG AND EMPTIED BLADDER. PATIENT TOLERATED WELL. AFTER THAT 50ML OF CHEMOTHERAPY INSTILLED INTO BLADDER THROUGH PORT ON CATHETER BAG AS PER PROTOCOL AND PATIENT TOLERATED WELL BUT, WHILE FLUSHING PORT WITH NS FLUSH, NURSE AND PATIENT HEARD A POP AND PATIENT WAS IN DISCOMFORT AND NEEDED TO VOID IMMEDIATELY. FOLEY BAG UNCLAMPED AND BLADDER DRAINED. NURSE ATTEMPTED TO DEFLATE BALLOON BUT UNABLE TO. FOLEY REMOVED AND BULB NOT INTACT, BURST. PATIENT WAS UP TO VOID INDEPENDENTLY POST REMOVAL AND REFUSED FURTHER CHEMO FOR THE DAY. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 18746801 ↗
• MalfunctionOct 5, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS DEFECTIVE. THE LOT NUMBER WAS UNKNOWN AS PACKAGING WAS NOT SAVED (BATCH# UNK). THE OFFICE HAD FOUR DIFFERENT LOT NUMBERS (BATCH# MYFT1395, BATCH# MYGZ4197, BATCH# MYGZ4503 AND BATCH# MYGQ6715). PER FOLLOW UP VIA EMAIL ON 13SEP2023, IT WAS REPORTED THAT IT WAS THE SAME PATIENT, AN OLDER MALE PALLIATIVE CLIENT (95 YEARS OF AGE). THE CATHETER BALLOONS REPORTEDLY BLEW WHILE INSIDE THEIR BLADDER (TWO CATHETERS REPORTED HAVING THE SAME ISSUE) CATHETERS WERE OUT, AND DAUGHTER PLACED THEM IN BAG FOR THE NURSES TO SEE. THERE WERE NO FURTHER MEDICAL INTERVENTIONS DONE. IT SEEMED NO HARM WAS DONE. ATTENDING NURSE REPLACED THE CATHETER. THEY TEMPORARILY PULLED ALL SIZE 14 FR. CATHETERS OFF THE SHELF AS THEY DID NOT KNOW THE LOT NUMBERS OF THOSE TWO CATHETERS. THEY TESTED FEW OTHER CATHETERS SAME SIZE DIFFERENT BATCHES AND THEY ALL LOOK FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17877167 ↗
• MalfunctionSep 26, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS DEFECTIVE. THE LOT NUMBER WAS UNKNOWN AS PACKAGING WAS NOT SAVED (BATCH# UNK). THE OFFICE HAD FOUR DIFFERENT LOT NUMBERS (BATCH# MYFT1395, BATCH# MYGZ4197, BATCH# MYGZ4503 AND BATCH# MYGQ6715). PER FOLLOW UP VIA EMAIL ON 13SEP2023, IT WAS REPORTED THAT IT WAS THE SAME PATIENT, AN OLDER MALE PALLIATIVE CLIENT (95 YEARS OF AGE). THE CATHETER BALLOONS REPORTEDLY BLEW WHILE INSIDE THEIR BLADDER (TWO CATHETERS REPORTED HAVING THE SAME ISSUE). CATHETERS WERE OUT, AND DAUGHTER PLACED THEM IN BAG FOR THE NURSES TO SEE. THERE WERE NO FURTHER MEDICAL INTERVENTIONS DONE. IT SEEMED NO HARM WAS DONE. ATTENDING NURSE REPLACED THE CATHETER. THEY TEMPORARILY PULLED ALL SIZE 14 FR. CATHETERS OFF THE SHELF AS THEY DID NOT KNOW THE LOT NUMBERS OF THOSE TWO CATHETERS. THEY TESTED FEW OTHER CATHETERS SAME SIZE DIFFERENT BATCHES AND THEY ALL LOOK FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816906 ↗
• MalfunctionSep 22, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS DEFECTIVE. THE LOT NUMBER WAS UNKNOWN AS PACKAGING WAS NOT SAVED (BATCH# UNK). THE OFFICE HAD FOUR DIFFERENT LOT NUMBERS (BATCH# MYFT1395, BATCH# MYGZ4197, BATCH# MYGZ4503 AND BATCH# MYGQ6715). PER FOLLOW UP VIA EMAIL ON 13SEP2023, IT WAS REPORTED THAT IT WAS THE SAME PATIENT, AN OLDER MALE PALLIATIVE CLIENT (95 YEARS OF AGE). THE CATHETER BALLOONS REPORTEDLY BLEW WHILE INSIDE THEIR BLADDER (TWO CATHETERS REPORTED HAVING THE SAME ISSUE) CATHETERS WERE OUT, AND DAUGHTER PLACED THEM IN BAG FOR THE NURSES TO SEE. THERE WERE NO FURTHER MEDICAL INTERVENTIONS DONE. IT SEEMED NO HARM WAS DONE. ATTENDING NURSE REPLACED THE CATHETER. THEY TEMPORARILY PULLED ALL SIZE 14 FR. CATHETERS OFF THE SHELF AS THEY DID NOT KNOW THE LOT NUMBERS OF THOSE TWO CATHETERS. THEY TESTED FEW OTHER CATHETERS SAME SIZE DIFFERENT BATCHES AND THEY ALL LOOK FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798291 ↗
• MalfunctionSep 22, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS DEFECTIVE. THE LOT NUMBER WAS UNKNOWN AS PACKAGING WAS NOT SAVED (BATCH# UNK). THE OFFICE HAD FOUR DIFFERENT LOT NUMBERS (BATCH# MYFT1395, BATCH# MYGZ4197, BATCH# MYGZ4503 AND BATCH# MYGQ6715). PER FOLLOW UP VIA EMAIL ON 13SEP2023, IT WAS REPORTED THAT IT WAS THE SAME PATIENT, AN OLDER MALE PALLIATIVE CLIENT (95 YEARS OF AGE). THE CATHETER BALLOONS REPORTEDLY BLEW WHILE INSIDE THEIR BLADDER (TWO CATHETERS REPORTED HAVING THE SAME ISSUE) CATHETERS WERE OUT, AND DAUGHTER PLACED THEM IN BAG FOR THE NURSES TO SEE. THERE WERE NO FURTHER MEDICAL INTERVENTIONS DONE. IT SEEMED NO HARM WAS DONE. ATTENDING NURSE REPLACED THE CATHETER. THEY TEMPORARILY PULLED ALL SIZE 14 FR. CATHETERS OFF THE SHELF AS THEY DID NOT KNOW THE LOT NUMBERS OF THOSE TWO CATHETERS. THEY TESTED FEW OTHER CATHETERS SAME SIZE DIFFERENT BATCHES AND THEY ALL LOOK FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17798287 ↗
• MalfunctionSep 21, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS DEFECTIVE. THE LOT NUMBER WAS UNKNOWN AS PACKAGING WAS NOT SAVED (BATCH# UNK). THE OFFICE HAD FOUR DIFFERENT LOT NUMBERS (BATCH# MYFT1395, BATCH# MYGZ4197, BATCH# MYGZ4503 AND BATCH# MYGQ6715). PER FOLLOW UP VIA EMAIL ON (B)(6) 2023, IT WAS REPORTED THAT IT WAS THE SAME PATIENT, AN OLDER MALE PALLIATIVE CLIENT (95 YEARS OF AGE). THE CATHETER BALLOONS REPORTEDLY BLEW WHILE INSIDE THEIR BLADDER (TWO CATHETERS REPORTED HAVING THE SAME ISSUE) CATHETERS WERE OUT, AND DAUGHTER PLACED THEM IN BAG FOR THE NURSES TO SEE. THERE WERE NO FURTHER MEDICAL INTERVENTIONS DONE. IT SEEMED NO HARM WAS DONE. ATTENDING NURSE REPLACED THE CATHETER. THEY TEMPORARILY PULLED ALL SIZE 14 FR. CATHETERS OFF THE SHELF AS THEY DID NOT KNOW THE LOT NUMBERS OF THOSE TWO CATHETERS. THEY TESTED FEW OTHER CATHETERS SAME SIZE DIFFERENT BATCHES AND THEY ALL LOOK FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788219 ↗
• InjuryJul 5, 2023Material Rupture; Material Rupture

  IT WAS REPORTED, THAT THE FOLEY CATHETER BALLOON BURST WHILE IN USE. THE EVENT OCCURRED DURING PATIENT USE, WITHIN 1-3 HOURS OF USE. THERE WAS NO REPORTED INJURY. HOWEVER, CATHETER BALLOON BURST, WHILE IN USE AND REMNANTS REMAINED IN BLADDER. THUS, PROLONGING ANESTHESIA WAS GIVEN TO RETRIEVE REMNANTS OF THE BURST BALLOON, STATED THAT THE SURGICAL STAFF NOTICED, THAT THE CATHETER WAS ON THE FLOOR UNDER THE PATIENT. PATIENT WAS GIVEN INDWELLING URINARY CATHETER, DURING GYNECOLOGICAL SURGICAL PROCEDURE, BEFORE POSITIONING READY FOR LAPAROSCOPIC PROCEDURE. APPROXIMATELY 2 HOURS INTO THE PROCEDURE, THE CATHETER WAS FOUND ON THE FLOOR UNDER THE PATIENT. CYSTOSCOPY WAS PERFORMED AND CONFIRMED, RETAINED/BURST BALLOON REMNANTS INSIDE BLADDER. GRASPER WAS REQUIRED TO RETRIEVE BROKEN/BURST LATEX BALLOON REMNANTS AND ALL REMNANTS WERE REMOVED. NO FURTHER SURGERY REQUIRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 17258864 ↗
• MalfunctionMay 26, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS DEFECTIVE. THE CATHETER FELL OUT OF PATIENT. NO APPARENT HARM REACHED THE PATIENT. THEY HAD INCONVENIENCE. STATED THAT THE PATIENT REQUIRED UNEXPECTED OR PROLONGED CARE.

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

  MAUDE report 17009633 ↗
• MalfunctionMay 26, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY BALLOON WAS DEFECTIVE AND THE CATHETER FELL OUT OF THE PATIENT. THERE WAS AN UNEXPECTED OR PROLONGED CARE. NO APPARENT HARM REACHED THE PATIENT.

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

  MAUDE report 17009555 ↗
• InjuryApr 20, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT OF THE PATIENT¿S BLADDER AT THE END OF SURGERY. THE SURGEON EXAMINED THE CATHETER AND DISCOVERED A PIECE OF THE BALLOON WAS MISSING. CYSTOSCOPY HAD TO BE DONE TO LOOK FOR THE MISSING PIECE, WHICH WAS FOUND AND REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14159543 ↗
• InjuryFeb 18, 2022Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED ON (B)(6) 2021, ATTEMPTED TO REMOVE ON (B)(6) 2021, BUT WAS UNABLE TO BE REMOVED BY DEFLATING THE BALLOON. THE CUSTOMER STATED THAT ONLY 7 ML OF THE 10 ML OF FLUID FROM THE BALLOON WAS PULLED BACK. SOME FLUID STARTED TO FILL IN THE SYRINGE AUTOMATICALLY, BUT THEN STOPPED AROUND THE 4 TO 5 ML MARK. MANUALLY USER PULLED BACK THE REMAINING FLUID UNTIL THERE WAS 7 ML IN THE SYRINGE. BUT THEY WERE UNABLE TO REMOVE ANY MORE FLUID FROM THE BALLOON. THE REMOVAL OF THE FOLEY WAS ATTEMPTED, BUT THERE WAS SIGNIFICANT RESISTANCE AND PAIN EXPRESSED BY THE PATIENT. AN ATTEMPT WAS MADE TO POP THE FOLEY BALLOON USING A GUIDEWIRE THROUGH THE BALLOON PORT, BUT IT WAS UNSUCCESSFUL. FOLEY WAS REMOVED VIA ULTRASOUND GUIDED NEEDLE POPPING OF THE FOLEY CATHETER THROUGH THE SUPRAPUBIC ROUTE. THE PATIENT EXPERIENCED SIGNIFICANT PAIN AND DISTRESS DUE TO THIS INCIDENT.

  Patient problems: Distress; Pain

  MAUDE report 13561994 ↗
• MalfunctionAug 12, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CATHETER HAD BROKEN INSIDE THE PATIENT. SO, PATIENT EXPERIENCED PAIN. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Pain

  MAUDE report 12312923 ↗
• MalfunctionAug 11, 2021Burst Container or Vessel; Material Fragmentation; Burst Container or Vessel; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS BROKEN AND IT CAUSED PAIN TO THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 27SEP2022, THE FOLEY BALLOON POPPED OR SPLIT INSIDE AND IT CAUSED PAIN TO THE PATIENT.

  Patient problems: Pain

  MAUDE report 12306908 ↗
• MalfunctionAug 11, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306907 ↗
• InjuryAug 11, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CATHETER WAS FOUND BROKEN INSIDE THE PATIENT AND UNEXPECTED MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 12306906 ↗
• MalfunctionJun 11, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POPPING SENSATION FOLLOWED BY A STINGING SENSATION IN GROIN/PENIS DURING THE USE OF FOLEY CATHETER. WRITER INSPECTED FOLEY CATHETER AND ON APPLYING GENTLE TRACTION, FOLEY CATHETER WAS REMOVED WITH NO RESISTANCE. DAMAGE NOTED TO FOLEY BALLOON AND IT WAS UNABLE TO DETERMINE IF ANY PIECES OF FOLEY CATHETER REMAIN IN PATIENT AFTER REMOVAL. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Burning Sensation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11986297 ↗
• MalfunctionMar 12, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY BALLOONS WERE NOT DEFLATING AND IT WAS IMPACTING PATIENT CARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474481 ↗
• InjuryMar 5, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS DIFFICULT TO DEFLATE AFTER COMPLETION OF A MEDICATION REGIMEN. ONLY 6 CC WAS ABLE TO BE REMOVED FROM THE BALLOON UPON REMOVAL ATTEMPT. THE FOLEY CONTINUED TO FUNCTION AND DRAIN URINE. THE INFLATION PORT WAS CUT AND AIR DID NOT COME OUT OF THE BALLOON. THE BALLOON WAS ULTIMATELY PUNCTURED AND DEFLATED BY THE HEALTHCARE PROVIDER. PER ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT VIA EMAIL ON (B)(6) 2021, THE DEVICE WAS REMOVED WITH A PERCUTANEOUS PUNCTURE BY THE UROLOGIST.

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

  MAUDE report 11423970 ↗
• MalfunctionDec 9, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER ALLEGEDLY BROKE WHEN INSERTED. THIS HAS HAPPENED THREE MORE TIMES. PER FOLLOW UP VIA REGIONAL PARTNER ON 21NOV2020, NO MISSING PIECES FOUND AND THERE WAS NO IMPACT TO THE PATIENT. PER FOLLOW UP INFORMATION RECEIVED ON 01DEC2020, IT WAS CONFIRMED THAT THESE FOUR EVENTS OCCURRED IN DIFFERENT PATIENT. THE STERILE WATER WAS USED TO INFLATE BALLOON. THE FOLEY CATHETER DID NOT UNDERGONE PRETEST TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10979600 ↗
• MalfunctionDec 7, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS BROKEN WHEN INSERTED. THIS WAS HAPPENED TWO MORE TIMES. PER FOLLOW UP VIA A REGIONAL PARTNER ON 21NOV2020 THERE WERE NO MISSING PIECES FOUND AND NO IMPACT TO THE PATIENT. PER FOLLOW UP INFORMATION RECEIVED ON 01DEC2020 IT WAS CONFIRMED THAT THESE FOUR EVENTS OCCURRED IN DIFFERENT PATIENTS. THE STERILE WATER WAS USED TO INFLATE THE BALLOON. THE FOLEY CATHETER DID NOT UNDERGO THE PRETEST TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10963260 ↗