Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119214MRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741046292), received between May 15, 2018 and Jan 26, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Difficult to Remove

  IT WAS REPORTED THAT THE INCIDENT ON JAN 13 AFTERNOON, A PATIENT HAD A NEUROLOGY PROCEDURE WHERE A FOLEY CATHETER WAS INSERTED DURING THE CASE. THE OPERATING ROOM TEAM WAS UNABLE TO DEFLATE THE BALLOON TO REMOVE THE CATHETER AT THE END OF THE PROCEDURE. IN POST ANESTHESIA CARE UNIT, UROLOGY WAS CONSULTED AND SUCCESSFULLY DEFLATED THE BALLOON. HOWEVER, THE DECISION WAS MADE TO REINFLATE THE BALLOON WITH 10CC AND KEEP THE CATHETER IN PLACE UNTIL THE PATIENT'S BEDREST ORDER WAS COMPLETED. LATER IN THE AFTERNOON, THEY RECEIVED AN ORDER TO DISCONTINUE THE CATHETER. DESPITE MULTIPLE ATTEMPTS, THEY WERE UNABLE TO WITHDRAW MORE THAN 4CC OF WATER FROM THE BALLOON. THE ON CALL UROLOGY RESIDENT WAS PAGED AND ULTIMATELY USED A GUIDEWIRE TO MANUALLY DEFLATE THE BALLOON INTERNALLY. THERE WAS NO PATIENT HARM WAS REPORTED.

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

  MAUDE report 24185885 ↗
• MalfunctionNov 6, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT INFLATION BALLOON POPPED ON FOLEY CATHETER, ON 3 DIFFERENT TEMPERATURE SENSING FOLEY CATHETERS FROM THE SAME PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23488452 ↗
• MalfunctionSep 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY LEAKING AROUND THE CATHETER AND NOT DRAINING INTO THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23108968 ↗
• MalfunctionJul 29, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED BY THE CUSTOMER STATED THAT THE FOLEY WITH HOLE BELOW BIFURCATION OF PORTS. WHEN WATER WAS CONNECTED TO THE BALLOON PORT FOR INFLATION, IT LEAKS OUT OF THE HOLE. PACKAGING WAS NOT AVAILABLE, BUT LOT ON SHELF CURRENTLY WAS: NGJT3529.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645416 ↗
• MalfunctionJul 24, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THEY HAD AN EVENT COME THROUGH FOR A 14 FR FOLEY CATHETER THAT SHOULD HAVE BEEN INFLATED WITH 10 ML OF STERILE WATER. THE REGISTERED NURSE WAS ONLY ABLE TO REMOVE 8 ML OF WATER. IT WAS ESTIMATED ABOUT 1 TO 2 ML OF RESIDUAL WATER WAS LEFT IN BALLOON. THEY TRIED RE INFLATING ONCE REMOVED AND FOUND THAT IT ONLY INFLATED ON ONE SIDE, NOT A FULL BALLOON. THEY COULD NOT GET IT TO DEFLATE COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587932 ↗
• MalfunctionApr 8, 2025Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT 14FR TEMPERATURE SENSING FOLEY CATHETER PLACED INTO PATIENT WITHOUT DIFFICULTY. UPON USING INCLUDED SYRINGE TO FILL BALLOON A THIN STREAM OF WATER WAS NOTED TO BE SHOOTING OUT FROM WHERE THE PORT FOR BALLOON ATTACHED TO THE FOLEY CATHETER. CATHETER WAS REMOVED FROM PATIENT WITHOUT DIFFICULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21797798 ↗
• MalfunctionFeb 3, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER WITH HOLE BELOW BIFURCATION OF PORTS. WHEN WATER WAS CONNECTED TO THE BALLOON PORT FOR INFLATION, IT LEAKED OUT OF THE HOLE. IT WAS NOTED THAT THE GIVEN LOT # WAS NGJT3529;.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292553 ↗
• MalfunctionSep 17, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BALLOON OF FOLEY CATHETER HAD A HOLE IN IT WHICH DID NOT ALLOW THE BALLOON TO STAY INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236109 ↗
• MalfunctionAug 7, 2024Flaked; Material Protrusion/Extrusion; Flaked; Material Protrusion/Extrusion

  IT WAS REPORTED THAT BRAIDED METAL TEMPERATURE WIRE INSIDE TEMPERATURE SENSING FOLEY CATHETER UNRAVELED AND BREECHED THE PLASTIC AT THE DISTAL END WHILE INDWELLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19931019 ↗
• MalfunctionFeb 21, 2023Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON FOLDED BACK ON ITSELF WHEN IT WAS REMOVED RESULTING IN DIFFICULT REMOVAL. IT WAS CREATED A RING THAT ADDED TO THE CATHETER CIRCUMFERENCE. THIS WAS THE SECOND TIME THIS HAS HAPPENED ON THIS UNIT. THE FIRST TIME WAS ALMOST COULD NOT GET THE CATHETER OUT OF THE LITTLE BOY. PER SAMPLE RECEIVED, THE MATERIAL NUMBER FOR THE RETURN CATHETER IS 165812 WHICH DOES NOT MATCH THE MATERIAL NUMBER IN THIS PR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16411394 ↗
• MalfunctionFeb 21, 2023Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON FOLDED BACK ON ITSELF WHEN IT WAS REMOVED RESULTING IN DIFFICULT REMOVAL. IT WAS CREATED A RING THAT ADDED TO THE CATHETER CIRCUMFERENCE. THIS WAS THE SECOND TIME THIS HAS HAPPENED ON THIS UNIT . THE FIRST TIME WAS ALMOST COULD NOT GET THE CATHETER OUT OF THE LITTLE BOY . PER SAMPLE RECEIVED, THE MATERIAL NUMBER FOR THE RETURN CATHETER IS 165812 WHICH DOES NOT MATCH THE MATERIAL NUMBER IN THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409612 ↗
• MalfunctionAug 16, 2019Deflation Problem; Device Dislodged or Dislocated; Deflation Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE TEMPERATURE SENSING FOLEY DEFLATED PREMATURELY AND FELL OUT OF THE PATIENT. IT WAS LATER REPORTED FROM THE FACILITY THAT THE BALLOON WAS NOT DEFLATED WHEN THE CATHETER FELL OUT OF THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8901825 ↗
• MalfunctionAug 9, 2019Deflation Problem; Material Puncture/Hole; Deflation Problem

  IT WAS REPORTED THAT A HOLE WAS OBSERVED IN THE FOLEY CATHETER AFTER INSERTION INTO A PATIENT. THE CATHETER WAS REPORTEDLY REMOVED AND REPLACED.

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

  MAUDE report 8879871 ↗
• MalfunctionSep 6, 2018Inaccurate Flow Rate; No Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT DRAINING. COMPLAINANT REPORTED THE CATHETER WAS REPLACED AND THEN DRAINED 3000CC OF URINE. IT WAS ALSO NOTED THE PATIENT WAS FEELING AGITATED AND RESTLESS; A PARALYTIC WAS REPORTEDLY USED FOR THE PATIENT'S AGITATION AND RESTLESSNESS.

  Patient problems: No Known Impact Or Consequence To Patient; Urinary Retention

  MAUDE report 7852768 ↗
• MalfunctionSep 6, 2018Inaccurate Flow Rate; Output Problem; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE TEMP SENSING FOLEY CATHETER WAS NOT DRAINING AND WAS REPLACED DUE TO INCOMPATIBILITY FOR MRI. COMPLAINANT REPORTED THAT WHEN THE CATHETER WAS REPLACED, THE PATIENT DRAINED 1200CC URINE.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem; Urinary Retention

  MAUDE report 7852520 ↗
• MalfunctionSep 6, 2018Inaccurate Flow Rate; No Device Output; Inaccurate Flow Rate

  IT WAS REPORTED THAT THERE WAS NO OUTPUT FROM THE TEMP SENSING CATHETER FOR 6 HOURS. COMPLAINANT REPORTED THE CATHETER WAS REPOSITIONED AND THE PATIENT GOT OUT 1.45L.

  Patient problems: No Known Impact Or Consequence To Patient; Urinary Retention

  MAUDE report 7850630 ↗
• MalfunctionSep 6, 2018Restricted Flow rate; Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT HAD A DIMINISHED URINE OUTPUT FOLLOWING LASIX, THE CATHETER WAS REPORTEDLY REPLACED AND THE PATIENT THEN DRAINED 2L.

  Patient problems: Urinary Retention

  MAUDE report 7850556 ↗
• MalfunctionSep 6, 2018Inaccurate Flow Rate; Adverse Event Without Identified Device or Use Problem; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT HAD A DIMINISHED URINE OUTPUT FOR OVER 4 HOURS; COMPLAINANT REPORTED THE TEMP SENSING CATHETER WAS REMOVED FROM THE STATLOCK AND THE TUBING WAS REPOSITIONED AND THE PATIENT DRAINED 850CC.

  Patient problems: Urinary Retention

  MAUDE report 7850552 ↗
• MalfunctionMay 15, 2018Deflation Problem; Deflation Problem; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PAIN WAS ALLEGEDLY EXPERIENCED SHORTLY AFTER THE TEMP SENSING CATHETER WAS PLACED. THE RN REMOVED THE CATHETER AND NOTED THAT ONLY 2CC OF FLUID WAS LEFT IN THE BALLOON, THE RN THEN REINFLATED THE BALLOON WITH 8CC SALINE, WHICH THEN LEAKED OUT. COMPLAINANT REPORTED THAT NO PIECES OF THE CATHETER BALLOON WAS OBSERVED TO BE MISSING.

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

  MAUDE report 7516336 ↗