Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119216MRecalls & reported problems

Summary

The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 00801741046308), received between May 26, 2017 and Jul 27, 2026 — classified as 10 injuries, 157 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (43 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 167 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50025331 ↗
• MalfunctionMay 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT SEVERAL STAFF MEMBERS HAD NOTICED THAT THE TEMPERATURE SENSING FOLEY CATHETER WAS LEAKING AROUND THE URETHRA IN BOTH MALES AND FEMALES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25265124 ↗
• MalfunctionMay 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT SEVERAL STAFF MEMBERS HAD NOTICED THAT THE TEMPERATURE SENSING FOLEY CATHETER WAS LEAKING AROUND THE URETHRA IN BOTH MALES AND FEMALES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25265123 ↗
• MalfunctionMay 16, 2026Disconnection

  IT WAS REPORTED BY THE CUSTOMER THAT DURING FOLEY PLACEMENT PROCESS WHEN ABOUT TO INFLATE THE BALLOON, THE CONNECTOR CUFF WHERE THE SYRINGE WITH SALINE ATTACHES CAME OFF (UNABLE TO INFLATE BALLOON).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25196024 ↗
• MalfunctionMay 6, 2026Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON BROKE AFTER INSERTION, CAUSING THE CATHETER TO FALL OUT. NEEDED A NEW FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25101910 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE MEDICAL INTENSIVE CARE UNIT THAT FIVE DIFFERENT PATIENTS EXPERIENCED LEAKING (PT 1, PT 2, PT 3, PT 4, PT 5) WITH SILICONE TEMPERATURE SENSING FOLEY CATHETERS BETWEEN (B)(6) 2026 AND (B)(6) 2026. ALL AFFECTED DEVICES WERE 16 FR FOLEY CATHETERS, NUMBER 1011818. THERE HAD BEEN FEWER REPORTS OF LEAKING SINCE THAT TIME. THE ICU ALSO REPORTED PREVIOUS ISSUES WITH THE WIRE RAISED OUT OF THE SILICONE MATERIAL, WHICH MADE THE FOLEY CATHETER ROUGH AND RESULTED IN SKIN BREAKDOWN FOR PATIENTS. NO MEDICAL INTERVENTION WAS REPORTED. NEW FOLEYS WERE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718540 ↗
• MalfunctionMar 30, 2026Material Protrusion/Extrusion

  IT WAS REPORTED BY THE MEDICAL INTENSIVE CARE UNIT THAT FIVE DIFFERENT PATIENTS EXPERIENCED LEAKING (PT 1, PT 2, PT 3, PT 4, PT 5) WITH SILICONE TEMPERATURE SENSING FOLEY CATHETERS BETWEEN (B)(6) 2026. ALL AFFECTED DEVICES WERE 16 FR FOLEY CATHETERS, NUMBER 1011818. THERE HAD BEEN FEWER REPORTS OF LEAKING SINCE THAT TIME. THE ICU ALSO REPORTED PREVIOUS ISSUES WITH THE WIRE RAISED OUT OF THE SILICONE MATERIAL, WHICH MADE THE FOLEY CATHETER ROUGH AND RESULTED IN SKIN BREAKDOWN FOR PATIENTS. NO MEDICAL INTERVENTION WAS REPORTED. NEW FOLEYS WERE INSERTED.

  Patient problems: Tissue Breakdown

  MAUDE report 24718489 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE MEDICAL INTENSIVE CARE UNIT THAT FIVE DIFFERENT PATIENTS EXPERIENCED LEAKING (PT 1, PT 2, PT 3, PT 4, PT 5) WITH SILICONE TEMPERATURE SENSING FOLEY CATHETERS BETWEEN 23JAN2026 AND 01FEB2026. ALL AFFECTED DEVICES WERE 16 FR FOLEY CATHETERS, NUMBER 1011818. THERE HAD BEEN FEWER REPORTS OF LEAKING SINCE THAT TIME. THE ICU ALSO REPORTED PREVIOUS ISSUES WITH THE WIRE RAISED OUT OF THE SILICONE MATERIAL, WHICH MADE THE FOLEY CATHETER ROUGH AND RESULTED IN SKIN BREAKDOWN FOR PATIENTS. NO MEDICAL INTERVENTION WAS REPORTED. NEW FOLEYS WERE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718449 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE MEDICAL INTENSIVE CARE UNIT THAT FIVE DIFFERENT PATIENTS EXPERIENCED LEAKING (PT 1, PT 2, PT 3, PT 4, PT 5) WITH SILICONE TEMPERATURE-SENSING FOLEY CATHETERS BETWEEN 1/23/2026 AND 2/1/2026. ALL AFFECTED DEVICES WERE 16 FR FOLEY CATHETERS, LAWSON NUMBER (B)(4). THERE HAD BEEN FEWER REPORTS OF LEAKING SINCE THAT TIME. THE ICU ALSO REPORTED PREVIOUS ISSUES WITH THE WIRE RAISED OUT OF THE SILICONE MATERIAL, WHICH MADE THE FOLEY CATHETER ROUGH AND RESULTED IN SKIN BREAKDOWN FOR PATIENTS (PT 6). NO MEDICAL INTERVENTION WAS REPORTED. NEW FOLEYS WERE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718200 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE (B)(6) CARE UNIT THAT FIVE DIFFERENT PATIENTS EXPERIENCED LEAKING WITH SILICONE TEMPERATURE-SENSING FOLEY CATHETERS BETWEEN (B)(6) 2026 AND (B)(6) 2026. ALL AFFECTED DEVICES WERE 16 FR FOLEY CATHETERS, LAWSON NUMBER 1011818. THERE HAD BEEN FEWER REPORTS OF LEAKING SINCE THAT TIME. THE ICU ALSO REPORTED PREVIOUS ISSUES WITH THE WIRE RAISED OUT OF THE SILICONE MATERIAL, WHICH MADE THE FOLEY CATHETER ROUGH AND RESULTED IN SKIN BREAKDOWN FOR PATIENTS. NO MEDICAL INTERVENTION WAS REPORTED. NEW FOLEYS WERE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24718195 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE MEDICAL INTENSIVE CARE UNIT THAT FIVE DIFFERENT PATIENTS EXPERIENCED LEAKING (PT 1, PT 2, PT 3, PT 4, PT 5) WITH SILICONE TEMPERATURE SENSING FOLEY CATHETERS BETWEEN 1/23/2026 AND 2/1/2026. ALL AFFECTED DEVICES WERE 16 FR FOLEY CATHETERS, LAWSON NUMBER 1011818. THERE HAD BEEN FEWER REPORTS OF LEAKING SINCE THAT TIME. THE ICU ALSO REPORTED PREVIOUS ISSUES WITH THE WIRE RAISED OUT OF THE SILICONE MATERIAL, WHICH MADE THE FOLEY CATHETER ROUGH AND RESULTED IN SKIN BREAKDOWN FOR PATIENTS (PT 6). NO MEDICAL INTERVENTION WAS REPORTED. NEW FOLEYS WERE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714509 ↗
• MalfunctionMar 11, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT REPORTED FELT A POP AND CALLED REGISTERED NURSE INTO THE ROOM. FOLEY CATHETER CAME OUT AND REGISTERED NURSE NOTICED THE BALLOON WAS SEEN AS POPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570963 ↗
• MalfunctionMar 5, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE FOLEY HAD SEQUESTERED. THE BALLOON HAD BEEN INFLATED WITH 10 CC OVER THE WEEKEND, AND BY MONDAY MORNING THE BALLOON WAS SMALLER, AS ONLY 5 CC WAS ASPIRATED. UPON REINFLATION, THE BALLOON WAS FOUND TO BE IRREGULARLY SHAPED. THIS EVENT WAS ONE OF MULTIPLE TEMPERATURE SENSING FOLEY INCIDENTS THAT HAD OCCURRED IN THE PAST FEW WEEKS. ADDITIONAL EVENTS WERE DESCRIBED IN THE ATTACHED QUESTIONNAIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24521050 ↗
• MalfunctionFeb 23, 2026Dent in Material

  IT WAS REPORTED THAT THE FOLEY HAD SEQUESTERED. THE BALLOON HAD BEEN INFLATED WITH 10 CC OVER THE WEEKEND, AND BY MONDAY MORNING THE BALLOON WAS SMALLER, AS ONLY 5 CC WAS ASPIRATED. UPON REINFLATION, THE BALLOON WAS FOUND TO BE IRREGULARLY SHAPED. THIS EVENT WAS ONE OF MULTIPLE TEMPERATURE SENSING FOLEY INCIDENTS THAT HAD OCCURRED IN THE PAST FEW WEEKS. ADDITIONAL EVENTS WERE DESCRIBED IN THE ATTACHED QUESTIONNAIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421294 ↗
• MalfunctionFeb 18, 2026Nonstandard Device

  IT WAS REPORTED THAT THE TEMPERATURE SENSING FOLEY CATHETER BALLOON WAS FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380534 ↗
• MalfunctionFeb 13, 2026Nonstandard Device

  IT WAS REPORTED THAT THE TEMPERATURE-SENSING FOLEY CATHETER BALLOON WAS FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24338835 ↗
• MalfunctionFeb 13, 2026Nonstandard Device

  IT WAS REPORTED THAT THE TEMPERATURE-SENSING FOLEY CATHETER BALLOON WAS FAILURE.

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

  MAUDE report 24338834 ↗
• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS BALLOON FAILURE ON TEMPERATURE SENSING FOLEY CATHETER. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 02 FEB 2026, IT WAS REPORTED THAT THERE HAD BEEN A FOLEY CATHETER THAT COULD NOT BE REMOVED. THE BALLOON HAD NOT DEFLATED, AND IT HAD TO BE REMOVED BY THE UROLOGY TEAM. AFTER REMOVAL, IT HAD BEEN NOTED THAT THE BALLOON WAS NOT ROUND. THE ICU HAD ALSO TRIED TWO ADDITIONAL KITS AND FOUND THAT THE BALLOONS HAD NOT DEFLATED. THE THIRD FOLEY TESTED IN THAT AREA HAD A BALLOON THAT DID DEFLATE. IN ANOTHER ICU, THERE HAD BEEN AN ISSUE IN WHICH THE FOLEY HAD STOPPED RECORDING TEMPERATURES. AN ADDITIONAL FOLEY IN THE SAME ICU HAD BEEN REPORTED TO BE LEAKING AROUND THE CATHETER. IT WAS ALSO REPORTED THAT IN THE STEP-DOWN AREA, ONE FOLEY HAD FALLEN OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24325055 ↗
• MalfunctionFeb 12, 2026Difficult to Remove

  IT WAS REPORTED THAT THERE WAS BALLOON FAILURE ON TEMPERATURE SENSING FOLEY CATHETER. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 02FEB2026, IT WAS REPORTED THAT THERE HAD BEEN A FOLEY CATHETER THAT COULD NOT BE REMOVED. THE BALLOON HAD NOT DEFLATED, AND IT HAD TO BE REMOVED BY THE UROLOGY TEAM. AFTER REMOVAL, IT WAS NOTED THAT THE BALLOON WAS NOT ROUND. THE ICU HAD ALSO TRIED TWO ADDITIONAL KITS AND FOUND THAT THE BALLOONS HAD NOT DEFLATED. THE THIRD FOLEY TESTED IN THAT AREA HAD A BALLOON THAT DID DEFLATE. IN ANOTHER ICU, THERE HAD BEEN AN ISSUE IN WHICH THE FOLEY HAD STOPPED RECORDING TEMPERATURES. AN ADDITIONAL FOLEY IN THE SAME ICU HAD BEEN REPORTED TO BE LEAKING AROUND THE CATHETER. IT WAS ALSO REPORTED THAT IN THE STEP DOWN AREA, ONE FOLEY HAD FALLEN OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324842 ↗
• MalfunctionFeb 12, 2026No Display/Image

  IT WAS REPORTED THAT THERE WAS BALLOON FAILURE ON TEMPERATURE SENSING FOLEY CATHETER. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2026, IT WAS REPORTED THAT THERE HAD BEEN A FOLEY CATHETER THAT COULD NOT BE REMOVED. THE BALLOON HAD NOT DEFLATED, AND IT HAD TO BE REMOVED BY THE UROLOGY TEAM. AFTER REMOVAL, IT WAS NOTED THAT THE BALLOON WAS NOT ROUND. THE ICU HAD ALSO TRIED TWO ADDITIONAL KITS AND FOUND THAT THE BALLOONS HAD NOT DEFLATED. THE THIRD FOLEY TESTED IN THAT AREA HAD A BALLOON THAT DID DEFLATE. IN ANOTHER ICU, THERE HAD BEEN AN ISSUE IN WHICH THE FOLEY HAD STOPPED RECORDING TEMPERATURES. AN ADDITIONAL FOLEY IN THE SAME ICU HAD BEEN REPORTED TO BE LEAKING AROUND THE CATHETER. IT WAS ALSO REPORTED THAT IN THE STEP DOWN AREA, ONE FOLEY HAD FALLEN OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324840 ↗
• MalfunctionFeb 12, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS BALLOON FAILURE ON TEMPERATURE SENSING FOLEY CATHETER. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 02FEB2026, IT WAS REPORTED THAT THERE HAD BEEN A FOLEY CATHETER THAT COULD NOT BE REMOVED. THE BALLOON HAD NOT DEFLATED, AND IT HAD TO BE REMOVED BY THE UROLOGY TEAM. AFTER REMOVAL, IT HAD BEEN NOTED THAT THE BALLOON WAS NOT ROUND. THE ICU HAD ALSO TRIED TWO ADDITIONAL KITS AND FOUND THAT THE BALLOONS HAD NOT DEFLATED. THE THIRD FOLEY TESTED IN THAT AREA HAD A BALLOON THAT DID DEFLATE. IN ANOTHER ICU, THERE HAD BEEN AN ISSUE IN WHICH THE FOLEY HAD STOPPED RECORDING TEMPERATURES. AN ADDITIONAL FOLEY IN THE SAME ICU HAD BEEN REPORTED TO BE LEAKING AROUND THE CATHETER. IT WAS ALSO REPORTED THAT IN THE STEP DOWN AREA, ONE FOLEY HAD FALLEN OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324839 ↗
• InjuryFeb 12, 2026Difficult to Remove

  IT WAS REPORTED THAT THERE WAS BALLOON FAILURE ON TEMPERATURE SENSING FOLEY CATHETER. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 02FEB2026, IT WAS REPORTED THAT THERE HAD BEEN A FOLEY CATHETER THAT COULD NOT BE REMOVED. THE BALLOON HAD NOT DEFLATED, AND IT HAD TO BE REMOVED BY THE UROLOGY TEAM. AFTER REMOVAL, IT HAD BEEN NOTED THAT THE BALLOON WAS NOT ROUND. THE ICU HAD ALSO TRIED TWO ADDITIONAL KITS AND FOUND THAT THE BALLOONS HAD NOT DEFLATED. THE THIRD FOLEY TESTED IN THAT AREA HAD A BALLOON THAT DID DEFLATE. IN ANOTHER ICU, THERE HAD BEEN AN ISSUE IN WHICH THE FOLEY HAD STOPPED RECORDING TEMPERATURES. AN ADDITIONAL FOLEY IN THE SAME ICU HAD BEEN REPORTED TO BE LEAKING AROUND THE CATHETER. IT WAS ALSO REPORTED THAT IN THE STEP DOWN AREA, ONE FOLEY HAD FALLEN OUT OF THE PATIENT.

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

  MAUDE report 24324838 ↗
• InjuryFeb 11, 2026Material Invagination; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT DEFLATE AND NEEDED TO BE REMOVED BY UROLOGY. PER FOLLOW INFORMATION RECEIVED ON 05FEB2026, THEY WERE UNABLE TO PROVIDE THE SERIAL NUMBER AS THE FOLEY DEVICE WAS NOT SEQUESTERED. THE FOLEY CATHETER NEEDED TO BE REMOVED BY UROLOGY. UROLOGY CAME TO THE UNIT TO REMOVE THE FOLEY WITH DIFFICULTY. BALLOON WAS REINFLATED AND DEFLATED TWICE BEFORE IT WAS ARCCED UP TO THE PROVIDER TEAM WHO THEN CONSULTED UROLOGY AS ATTEMPTING TO PULL THE FOLEY OUT WAS CAUSING THE PATIENT DISCOMFORT/PAIN. HEN UROLOGY PULLED OUT THE FOLEY, THE NURSE WITNESSED THE FOLEY TIP AND THE TIP HAD PULLED INWARD, CAUSING A DONUT SHAPED RING TO FORM WHERE THE BALLOON WAS. THERE WAS NO LIQUID IN THIS RING. THIS RING WAS WHAT MADE THE FOLEY REMOVAL DIFFICULT. THERE WERE ADDITIONAL TWO MORE INSTANCES OF FOLEY CONCERNS BACK IN MID-DECEMBER WHERE THE REPORTED NURSES WENT TO INSERT THE FOLEY, TESTED THE BALLOON AND BALLOON DID NOT DEFLATE. THEY OBTAINED A SECOND KIT, AND THE SECOND KIT DID THE SAME. THEY TRIED A THIRD KIT AND THE THIRD KIT WORKED SO THE THIRD KIT WAS USED. I ALSO DO NOT HAVE THOSE FOLEYS OR ITEM NUMBERS SEQUESTERED. ANOTHER UNIT HAD EXPERIENCED A FOLEY LE

  Patient problems: Discomfort; Pain

  MAUDE report 24318284 ↗
• MalfunctionFeb 11, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON FAILURE ON TEMPERATURE SENSING FOLEY CATHETER. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 02FEB2026, IT WAS REPORTED THAT THERE HAD BEEN A FOLEY CATHETER THAT COULD NOT BE REMOVED. THE BALLOON HAD NOT DEFLATED, AND IT HAD TO BE REMOVED BY THE UROLOGY TEAM. AFTER REMOVAL, IT HAD BEEN NOTED THAT THE BALLOON WAS NOT ROUND. THE ICU HAD ALSO TRIED TWO ADDITIONAL KITS AND FOUND THAT THE BALLOONS HAD NOT DEFLATED. THE THIRD FOLEY TESTED IN THAT AREA HAD A BALLOON THAT DID DEFLATE. IN ANOTHER ICU, THERE HAD BEEN AN ISSUE IN WHICH THE FOLEY HAD STOPPED RECORDING TEMPERATURES. AN ADDITIONAL FOLEY IN THE SAME ICU HAD BEEN REPORTED TO BE LEAKING AROUND THE CATHETER. IT WAS ALSO REPORTED THAT IN THE STEP DOWN AREA, ONE FOLEY HAD FALLEN OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318282 ↗
• MalfunctionFeb 11, 2026Material Rupture

  IT WAS REPORTED THAT THERE WAS BALLOON FAILURE ON TEMPERATURE SENSING FOLEY CATHETER. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON 02FEB2026, IT WAS REPORTED THAT THERE HAD BEEN A FOLEY CATHETER THAT COULD NOT BE REMOVED. THE BALLOON HAD NOT DEFLATED, AND IT HAD TO BE REMOVED BY THE UROLOGY TEAM. AFTER REMOVAL, IT HAD BEEN NOTED THAT THE BALLOON WAS NOT ROUND. THE ICU HAD ALSO TRIED TWO ADDITIONAL KITS AND FOUND THAT THE BALLOONS HAD NOT DEFLATED. THE THIRD FOLEY TESTED IN THAT AREA HAD A BALLOON THAT DID DEFLATE. IN ANOTHER ICU, THERE HAD BEEN AN ISSUE IN WHICH THE FOLEY HAD STOPPED RECORDING TEMPERATURES. AN ADDITIONAL FOLEY IN THE SAME ICU HAD BEEN REPORTED TO BE LEAKING AROUND THE CATHETER. IT WAS ALSO REPORTED THAT IN THE STEP DOWN AREA, ONE FOLEY HAD FALLEN OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318281 ↗