Bardex Lubri-Sil All-Silicone Temp Sensing Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 198
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 5 models of Bardex Lubri-Sil All-Silicone Temp Sensing Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 198 adverse event reports in the FDA's MAUDE database, received between May 26, 2017 and Jul 27, 2026 — classified as 11 injuries, 187 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (48 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bardex Lubri-Sil All-Silicone Temp Sensing Foley Catheter problems
Device problems
- Material Puncture/Hole48
- Fluid/Blood Leak39
- Deflation Problem17
- Difficult to Remove15
- Inaccurate Flow Rate13
- Decrease in Pressure9
- Material Invagination8
- Material Split, Cut or Torn8
Patient problems
- No Clinical Signs, Symptoms or Conditions127
- No Consequences Or Impact To Patient52
- No Known Impact Or Consequence To Patient38
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- Pain6
- Urinary Retention6
- Discomfort4
- No Information3
Bardex Lubri-Sil All-Silicone Temp Sensing Foley Catheter models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119216MCATHETER, RETENTION TYPE, BALLOON167 reports
- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119214MCATHETER, RETENTION TYPE, BALLOON19 reports
- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119208MCATHETER, RETENTION TYPE, BALLOON5 reports
- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119218MCATHETER, RETENTION TYPE, BALLOON5 reports
- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119210MCATHETER, RETENTION TYPE, BALLOON2 reports
Recent Bardex Lubri-Sil All-Silicone Temp Sensing Foley Catheter adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionApr 3, 2026No Display/Image
IT WAS REPORTED THAT PATIENT HAD A TEMPERATURE SENSING FOLEY CATHETER THAT WAS NOT READING THE PATIENT TEMPERATURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24784294 ↗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 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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