Bardex® Lubri-Sil® All-Silicone Foley Catheter 73016LRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741034299), received between Jun 6, 2017 and Mar 17, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE SECOND FOLEY CATHETER THAT HAS HAD A BALLOON COLLAPSE DUE TO A VISIBLY OBVIOUS DEFECT IN THE PRODUCT ITSELF. THE LOT NUMBER PROVIDED IS FOR THE NEW CATHETER OF THE SAME TYPE THAT WAS PUT IN 12MAR2026, FOLLOWING TWO UNINTENTIONAL REMOVALS OF THE FOLEY CATHETER, THEY FELL OUT. CATHETER REMAINED INTACT, BUT BALLOON SEAMS SHOWED OBVIOUS MALFORMATION. THEY WERE UNABLE TO RETRIEVE THE PACKAGING FROM THE DEFORMED CATHETERS, AS THE GARBAGE HAS ALREADY BEEN REMOVED FROM THE ROOM. OLD PRODUCT AVAILABLE IN BIOHAZARD BAG AS NEEDED. LOT NGKY1943.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622366 ↗
• MalfunctionSep 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A 3V CH16 SILICONE URINARY CATHETER REFERENCE (B)(4) THAT DEVELOPED A QUALITY DEFECT IN CUSTOMER'S FACILITY. THE AFFECTED LOT NUMBER WAS NGGX4189. IN PRACTICE, AFTER INSERTION IN THE PATIENT'S HOME, THE CATHETER DEVELOPED A LEAK AT THE THREE-WAY SEPARATION. THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER CATHETER; ANOTHER LOT NUMBER WAS AVAILABLE AT THE DEPARTMENT, WITH NO APPARENT HARM TO THE PATIENT. THE CATHETER WAS NOT RETAINED; ONLY THE PACKAGING WAS PROVIDED TO THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098441 ↗
• MalfunctionAug 13, 2024Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE PATIENT ARRIVED FOR POST BRACHYTHERAPY FOR CATHETER REMOVAL. PATIENT WAS IN PAIN AND WAS HAVING A HARD TIME WALKING DUE TO THE PAIN. THE USER DEFLATED 20 ML OUT OF BALLOON AND PULLED CATHETER WITH RESISTANCE. PATIENT HAD A GREAT DEAL OF PAIN. OPERATING ROOM WAS USING ALL-SILICONE FOLEY CATHETER 16 FRENCH. THE BALLOON DEFLATES BUT THE SILICONE ROLLS AND CREATES A CUFF. PATIENT WAS ALMOST IN TEARS FROM THE PAIN. PATIENT STATED BLADDER SPASM AND 9/10 PAIN SHAFT OF PENIS. NO MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain

  MAUDE report 19975500 ↗
• MalfunctionApr 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE URINE LEAKED FROM A SMALL PINPOINT AREA (BELOW BIFURCATION AREA) OF THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192868 ↗
• MalfunctionJan 2, 2024Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT FOUR CATHETERS WERE INSERTED, AND ALL FOUR BALLOONS RUPTURED WITHIN A FEW HOURS. PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 04-DEC-2023, THE FACILITY STATED THEY HAVE SENT THE DEFECTIVE CATHETERS BACK AS PER THE INSTRUCTIONS RECEIVED. THE CATHETERS WERE ALL FROM THE SAME PATIENT. THE IMPACT WAS THAT A DYING PATIENT REQUIRED MULTIPLE CATHETER INSERTIONS DUE TO THE DEFECTS. PER MAIL RECEIVED ON 07-DEC-2023, THE CUSTOMER RETURNED TWO (2) ADDITIONAL ALL-SILICONE FOLEY CATHETERS. ADDITIONAL CLINICAL FOLLOW UP INFORMATION WAS RECEIVED VIA EMAIL ON 13-DEC-2023. THE NURSE REPORTED THE EVENT OCCURRED AROUND (B)(6) 2023, BUT SHE WAS UNABLE TO PROVIDE THE EXACT DATE. THE BALLOONS WERE INSPECTED, AND THE RUPTURES APPEARED TO BE CLEAN. THERE WERE NO PIECES OF THE BALLOONS RETAINED IN THE PATIENT. THE NURSE CONFIRMED THE PATIENT WAS DECEASED AND REPORTED THE PATIENT¿S DEATH WAS UNRELATED TO FOLEY CATHETERS. SHE WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424604 ↗
• MalfunctionDec 26, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT FOUR (4) FOLEY CATHETERS WERE INSERTED, AND ALL FOUR (4) BALLOONS RUPTURED WITHIN A FEW HOURS (BATCH# NGHQ3504 AND BATCH# NGHV1184). PER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 04-DEC-2023, THE FACILITY STATED THEY HAVE SENT THE DEFECTIVE CATHETERS BACK AS PER THE INSTRUCTIONS RECEIVED. THE CATHETERS WERE ALL FROM THE SAME PATIENT. THE IMPACT WAS THAT A DYING PATIENT REQUIRED MULTIPLE CATHETER INSERTIONS DUE TO THE DEFECTS. PER MAIL RECEIVED ON 07-DEC-2023, THE CUSTOMER RETURNED TWO (2) ADDITIONAL ALL-SILICONE FOLEY CATHETERS. ADDITIONAL CLINICAL FOLLOW UP INFORMATION WAS RECEIVED VIA EMAIL ON 13-DEC-2023. THE NURSE REPORTED THE EVENT OCCURRED AROUND (B)(6) 2023 TO (B)(6) 2023, BUT THEY WERE UNABLE TO PROVIDE THE EXACT DATE. THE BALLOONS WERE INSPECTED, AND THE RUPTURES APPEARED TO BE CLEAN. THERE WERE NO PIECES OF THE BALLOONS RETAINED IN THE PATIENT. THE NURSE CONFIRMED THE PATIENT WAS DECEASED AND REPORTED THE PATIENT¿S DEATH WAS UNRELATED TO FOLEY CATHETERS. THEY WERE UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18392278 ↗
• MalfunctionNov 27, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT FOUR CATHETERS WERE INSERTED AND ALL FOUR BALLOONS RUPTURED WITHIN A FEW HOURS (BATCH# NGHQ3504 AND BATCH# NGHV1184).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209859 ↗
• MalfunctionNov 27, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT FOUR CATHETERS WERE INSERTED AND ALL FOUR BALLOONS RUPTURED WITHIN A FEW HOURS (BATCH# NGHQ3504 AND BATCH# NGHV1184).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209302 ↗
• MalfunctionAug 28, 2023Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE PATIENT NEEDED A CATHETER REMOVED DUE TO DISCOMFORT. THE PATIENT WAS PRESENTED TO THE DAYROOM AREA AT THE HOSPITAL, AND A 10-ML SYRINGE WAS USED TO DEFLATE THE BALLOON. ABOUT 20 ML OF FLUID WAS REMOVED, AND THE CATHETER WAS PULLED WITH SOME RESISTANCE. THE NURSE DOUBLE-CHECKED WHETHER ALL THE FLUID WAS REMOVED BUT STILL COULDN'T REMOVE THE CATHETER DUE TO RESISTANCE. THE NURSE TRIED AGAIN AND WAS ABLE TO REMOVE THE CATHETER, BUT THE PATIENT STATED THAT IT WAS VERY PAINFUL. THE TIP OF THE CATHETER APPEARED TO HAVE A CUFF THAT WAS LARGER THAN THE REST OF THE TIP, DESPITE ALL FLUID BEING REMOVED. THE BALLOON APPEARED DEFLATED WITH A FLAP OF THE TUBING ROLLED OR BUNCHED UP. THE NURSE THAT HAD INSERTED THE FOLEY STATED THAT IT WAS ONLY ORIGINALLY INFLATED WITH 20 CC INSTEAD OF THE 35 CC FILL CAPACITY.

  Patient problems: Pain

  MAUDE report 17630700 ↗
• MalfunctionJan 9, 2020Unintended Ejection; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A LEAK HAPPENED DURING BLADDER WASHING AT THE WELDED PART OF THE CATHETER.

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

  MAUDE report 9568654 ↗
• MalfunctionJun 6, 2017Leak/Splash

  IT WAS REPORTED THAT THE CATHETER LEAKED NEAR THE 3 WAY VALVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6615994 ↗