Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 70516SIRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741025433), received between Feb 10, 2022 and Jul 31, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (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, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE WRITER ATTEMPTED TO INSERT A 16F 3-WAY FOLEY (HMMS: 170913) ON MY PALLIATIVE PATIENT. WHEN WRITER INSERTED FOLEY, WRITER NOTICED MODERATE AMOUNT OF URINE DRIPPING FROM THE END OF THE FOLEY WHERE THE TUBE DRIFTS TO 3-WAY PORTS. WRITER HAD A CLINICAL EXTERN DYLAN R. OBSERVING CATHETER INSERTION. WRITER ASKED COWORKER EMILY M. RPN TO WITNESS FAULTY CATHETER. DYLAN OBTAINED ANOTHER 16F 3-WAY (SAME CATHETER) CATHETER WAS INSPECTED BEFORE INSERTION, IT APPEARED TO BE DEFECTED AS WELL. DYLAN OBTAINED A 14F 2-WAY FOLEY THAT WAS INSPECTED AND APPEARED TO BE IN GOOD WORKING ORDER. WRITER INSERTED 14F FOLEY WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674946 ↗
• MalfunctionJul 31, 2025Nonstandard Device; Defective Device; Nonstandard Device; Defective Device

  IT WAS REPORTED THAT THE WRITER ATTEMPTED TO INSERT A 16F 3-WAY FOLEY (HMMS: 170913) ON MY PALLIATIVE PATIENT. WHEN WRITER INSERTED FOLEY, WRITER NOTICED MODERATE AMOUNT OF URINE DRIPPING FROM THE END OF THE FOLEY WHERE THE TUBE DRIFTS TO 3-WAY PORTS. WRITER HAD A CLINICAL EXTERN (B)(6). OBSERVING CATHETER INSERTION. WRITER ASKED COWORKER (B)(6). RPN TO WITNESS FAULTY CATHETER. (B)(6) OBTAINED ANOTHER 16F 3-WAY (SAME CATHETER) CATHETER WAS INSPECTED BEFORE INSERTION, IT APPEARED TO BE DEFECTED AS WELL. (B)(6) OBTAINED A 14F 2-WAY FOLEY THAT WAS INSPECTED AND APPEARED TO BE IN GOOD WORKING ORDER. WRITER INSERTED 14F FOLEY WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674944 ↗
• MalfunctionSep 24, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE 8 FOLEY CATHETERS CONTAINED DEBRIS, HAIR AND BLACK SPECKS WITHIN THE STERILE WRAPPER. AS PER FOLLOW UP VIA PHONE ON 20SEP2022, STATED THAT THE CATHETERS DID NOT COME INTO CONTACT WITH ANY PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476240 ↗
• MalfunctionJun 3, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE PATIENT HAD FALL OUT IN THE SECOND FOLEY CATHETER AND BALLOONS WERE FALLING OUT. NURSES CONFIRMED 10CC WAS GOING INTO BALLOON. PATIENT HAD CHANGED OWN CATHETER BALLOONS WHICH WERE DEFLATING ABOUT EVERY TWO WEEKS INCLUDING THE ONE PLACED BY THE MAYO HOSPITAL THE THIRD PORT DID NOT HAVE A PLUG THAT FIT PROPERLY THE PLUG WE HAVE DID NOT FIT. PATIENT ALSO STATED THAT THE YELLOW PLUGS WERE TO BIG FOR THIRD PORT ON WHOLE THAT DID NOT WENT INTO THE PORT WHOLE ALL THE WAY BUT ONLY ABOUT A QUARTER INCH INTO THE PORT, WHILE PATIENT WAS SLEEPING THE PLUG FELL OUT ALLOT CAUSING THE PATIENT COME WET. PATIENT NEEDED A THREE PORT FOR TAKING URINE SAMPLES. PATIENT ALSO STATED THAT THE CATHETER WERE TO LONG FOR WOMEN WHO WEAR DRESSES SO PATIENT WAS CUTTING EXTENDER. PATIENT COULD NOT FEEL WHEN THEY WERE STARTING TO DEFLATE THEY WERE DEFLATING IN THE MIDDLE OF THE NIGHT. PATIENT WAS WAKING UP WET IT WAS FALLING OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14591765 ↗
• MalfunctionMay 31, 2022Incorrect Measurement; Device Handling Problem; Incorrect Measurement; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT HAD FALL OUT IN THE SECOND FOLEY CATHETER AND BALLOONS WERE FALLING OUT. NURSES CONFIRMED 10CC WAS GOING INTO BALLOON. PATIENT HAD CHANGED OWN CATHETER BALLOONS WERE DEFLATING ABOUT EVERY TWO WEEKS INCLUDING THE ONE PLACED BY THE (B)(6) HOSPITAL. THE THIRD PORT DID NOT HAVE A PLUG THAT FIT PROPERLY THE PLUG WE HAVE DID NOT FIT. PATIENT ALSO STATED THAT THE YELLOW PLUGS WERE TO BIG FOR THIRD PORT WHOLE THEY DID NOT WENT INTO THE PORT WHOLE ALL THE WAY ONLY ABOUT A QUARTER INCH INTO THE PORT WHILE PATIENT WAS SLEEPING THE PLUG FELL OUT ALLOT CAUSING THE PATIENT COME WET. PATIENT NEEDED A THREE PORT FOR TAKING URINE SAMPLES. PATIENT ALSO STATED THAT THE CATHETER WERE TO LONG FOR WOMEN WHO WEAR DRESSES SO PATIENT WAS CUTTING EXTENDER. PATIENT COULD NOT FEEL WHEN THEY WERE STARTING TO DEFLATE THEY WERE DEFLATING IN THE MIDDLE OF THE NIGHT. PATIENT WAS WAKING UP WET IT WAS FALLING OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547928 ↗
• MalfunctionMay 31, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE PATIENT HAD FALL OUT IN THE SECOND FOLEY CATHETER AND BALLOONS WERE FALLING OUT . NURSES CONFIRMED 10CC WAS GOING INTO BALLOON. PATIENT HAD CHANGED OWN CATHETER BALLOONS WERE DEFLATING ABOUT EVERY TWO WEEKS INCLUDING THE ONE PLACED BY THE (B)(6) HOSPITAL . THE THIRD PORT DID NOT HAVE A PLUG THAT FIT PROPERLY THE PLUG WE HAVE DID NOT FIT . PATIENT ALSO STATED THAT THE YELLOW PLUGS WERE TO BIG FOR THIRD PORT WHOLE THEY DID NOT WENT INTO THE PORT WHOLE ALL THE WAY ONLY ABOUT A QUARTER INCH INTO THE PORT WHILE PATIENT WAS SLEEPING THE PLUG FELL OUT ALLOT CAUSING THE PATIENT COME WET. PATIENT NEEDED A THREE PORT FOR TAKING URINE SAMPLES. PATIENT ALSO STATED THAT THE CATHETER WERE TO LONG FOR WOMEN WHO WEAR DRESSES SO PATIENT WAS CUTTING EXTENDER. PATIENT COULD NOT FEEL WHEN THEY WERE STARTING TO DEFLATE THEY WERE DEFLATING IN THE MIDDLE OF THE NIGHT. PATIENT WAS WAKING UP WET IT WAS FALLING OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547163 ↗
• MalfunctionMay 4, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT AND NEEDED REPLACEMENT. PER ADDITIONAL INFORMATION RECEIVED ON 09APR2022, THE FOLEY CATHETER FALL OUT BECAUSE THE BALLOON DEFLATED, THEN THE LIQUID LEAKED OUT OF IT. THE FOLEY CATHETERS WERE TOO LONG. THE EMPTYING SIDE NEEDED A CAP OR URINE JUST POURED OUT AND NO CAP FITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283208 ↗
• MalfunctionMay 4, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT AND NEEDED REPLACEMENT. PER ADDITIONAL INFORMATION RECEIVED ON 09APR2022, THE FOLEY CATHETER FALL OUT BECAUSE THE BALLOON DEFLATED, THEN THE LIQUID LEAKED OUT OF IT. THE FOLEY CATHETERS WERE TOO LONG. THE EMPTYING SIDE NEEDED A CAP OR URINE JUST POURED OUT AND NO CAP FITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14278472 ↗
• MalfunctionFeb 10, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE URINE WAS COMING OUT OF BOTH PORTS IN FOLEY CATHETER AND ONE OF THE FOLEY CATHETERS DID NOT COME WITH A PLUG. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509153 ↗