Bardex® Lubri-Sil® All-Silicone Foley Catheter 175810Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741034282), received between Feb 26, 2019 and May 28, 2026 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Material Rupture

  IT WAS REPORTED THAT THEY HAD A DEFECTIVE 10F FOLEY. IT INSERTED AND THEN DID NOT HOLD WATER IN THE BALLOON. THE CATHETER FELL OUT AND THERE WAS A TEAR NOTED TO THE BALLOON. THEY HAD PULLED THIS LOT AS PRECAUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25323329 ↗
• MalfunctionDec 16, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THEY DISCOVERED THAT ALL OF OUR SUPPLY OF BARD LUBRI SIL ALL SILICONE FOLEY CATHETERS SIZES 8FR TO 20FR IN THE STOLLERY OR LEVEL 1 CORE HAVE LABELLING DISCREPANCIES. THE LOT NUMBER ON OUTSIDE OF PACKAGE DID NOT MATCH WITH LOT NUMBER ON PRODUCT INSIDE PACKAGE. THE BALLOON FILL AMOUNTS DID NOT MATCH ON THE 20FR AND 12FR PRODUCTS OR PACKAGING. THE REFERENCE NUMBERS DO APPEAR TO MATCH WITH PRODUCT AND PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822588 ↗
• MalfunctionOct 28, 2025Inadequate Instructions for Healthcare Professional; Unclear Information; Inadequate Instructions for Healthcare Professional; Unclear Information

  IT WAS REPORTED THAT THE AGE APPROPRIATE FOLEY CATHETER WAS SELECTED AND INSERTED AS PER PHYSICIANS' ORDERS. FOLEY INSERTION DONE PRIOR TO LAPAROSCOPIC APPENDECTOMY BY REGISTERED NURSE IN ROOM. THERE WAS A DISCREPANCY BETWEEN PACKAGE AND FOLEY, REGARDING THE BALLOON INFLATION AMOUNT. 10FRENCH FOLEY PACKAGE SAID TO INFLATE WITH 3ML BUT THE FOLEY ITSELF SAID TO INFLATE TO 5ML. 5ML WAS INFLATED AND UPON REMOVAL, 5ML OF WATER WAS REMOVED FROM BALLOON, RESISTANCE WAS HAD. OTHER NURSES IN ROOM, ANESTHESIA AND RESIDENTS ATTEMPTED TO REMOVE IT BUT COULD NOT. PRIMARY SURGEON CALLED BACK, AND HE COMPLETED THE REMOVAL. UPON REMOVAL A RIDGE WAS FOUND ON THE END OF THE FOLEY DEVICE. THIS WAS THE CAUSE OF THE RESISTANCE. PACKAGE AND FOLEY WERE KEPT FOR MANUFACTURERS. "PROLONGED ANESTHESIA DUE TO THIS" AND HIGHEST LEVEL OF HARM ADJUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405791 ↗
• MalfunctionMar 25, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT FOLEY CATHETER WAS PLACED IN A CHILD IN THE ED AND COULD NOT BE REMOVED. THEY NECESSITATED TRANSFER TO SEATTLE WHERE THE CATHETER WAS REMOVED. THEY QUESTIONED THE UNIT WHERE THE PATIENT WAS TRANSFERRED TO BE CONTACTED TO RETRIEVE THE CATHETER. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, IT WAS UNKNOWN AT THIS TIME FOR THE IMPACT TO THE PATIENT DUE TO THE DEVICE BESIDES NEEDING TO BE TRANSFERRED TO A DIFFERENT FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967936 ↗
• MalfunctionFeb 23, 2024Material Invagination; Difficult to Remove; Material Invagination; Difficult to Remove

  IT WAS REPORTED THAT BALLOON FOR SILICONE FOLEY CATHETER DID NOT DEFLATE ALL THE WAY AND CAUSED CUFFING AND A TRAUMATIC REMOVAL.

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

  MAUDE report 18768732 ↗
• MalfunctionJan 12, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN THE FOLEY CATHETER BALLOON WAS INFLATED IT LEAKED. CUSTOMER STATED IT WAS HAPPENED WITH ALL SIZES. (10FR 3CC BALLOON - PCN 175810, 12FR 5CC BALLOON - PCN 165812, 14FR 5CC BALLOON - PCN 165814 AND 16FR 5CC BALLOON - PCN 175816).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503039 ↗
• MalfunctionApr 21, 2022Material Invagination; Material Invagination

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD DEFLATE ON ITSELF AND WAS CREATING A RIDGE THAT REQUIRES EXCESSIVE FORCE TO REMOVE. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON (B)(6) 2022, TIP OF THE PENIS LOOKS REDDENED. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Skin Discoloration

  MAUDE report 14166235 ↗
• MalfunctionApr 20, 2022Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WOULD DEFLATE ON ITSELF AND CREATING A RIDGE THAT REQUIRES EXCESSIVE FORCE TO REMOVE. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON (B)(6) 2022, TIP OF PENIS LOOKS REDDENED. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164720 ↗
• InjuryApr 18, 2022Material Invagination; Material Invagination

  IT REPORTED THAT THE FOLEY CATHETER BALLOON WOULD NOT DEFLATE PROPERLY, IT BALLOONED AROUND ITSELF CREATING A RIDGE THAT MADE IT UNABLE TO REMOVE WITHOUT EXCESSIVE FORCE. STATED UNDER ANESTHETIC, THE FOLEY HAD TO BE REINSERTED AND REMOVED IN NOT IDEAL CONDITIONS. THERE WAS AN INFECTION RISK. STATED THAT COULD BE UNCOMFORTABLE IF PATIENT WAS AWAKE.

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

  MAUDE report 14136885 ↗
• MalfunctionFeb 18, 2022Material Invagination; Difficult to Remove; Material Invagination; Difficult to Remove

  IT WAS REPORTED THAT WHEN THE USER TRIED TO REMOVE THE FOLEY CATHETER BULB, IT WOULD NOT DEFLATE FULLY WHICH MADE THE CATHETER TO BE LODGED AT THE TIP OF THE URETHRA. THE PATIENT WAS ANESTHETIZED, OTHERWISE IT WOULD HAVE BEEN VERY PAINFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13563316 ↗
• MalfunctionSep 16, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT WHEN THE FOLEY CATHETER WAS INSERTED, THE OUTPUT WAS MINIMAL. STATED THAT FOLEY WAS IRRIGATED WITHOUT RESULTS. WHEN UROLOGIST WAS CALLED TO EVALUATE AGAIN, IT WOULD BE ABLE TO FLUSH WITH NO RETURN. CUSTOMER STATED THAT NEW FOLEY PLACED AND FUNCTIONING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484667 ↗
• MalfunctionMay 27, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THERE WAS RESISTANCE REMOVING FROM THE URETHRA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895110 ↗
• InjuryMar 1, 2019Deflation Problem; Difficult to Remove; Deflation Problem

  IT WAS REPORTED THAT THE BARDEX LUBRISIL FOLEY CATHETER WAS DIFFICULT TO REMOVE FROM THE PATIENT, AND ULTIMATELY REQUIRED SURGERY TO REMOVE. AN ATTEMPT WAS MADE TO POP THE BALLOON WITH AN ANGIOWIRE BUT WAS UNSUCCESSFUL. THE INFLATION VALVE WAS ALSO CUT, AND THE BALLOON WAS OVER-INFLATED , AND NEITHER DEFLATED THE BALLOON. THE PATIENT EXPERIENCED BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 8382067 ↗
• MalfunctionFeb 27, 2019Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVE AFTER THE SALINE WAS WITHDRAWN FROM THE BALLOON. THE CATHETER WAS REMOVED BY USING A LUBRICANT AND MANUAL MANIPULATION. THE PATIENT VOIDED AFTER THE REMOVAL WITHOUT DIFFICULTY. ONCE REMOVED, THE NURSE TRIED TO FILL THE BALLOON AGAIN WITH SALINE, AND NOTICED THE BALLOON WAS ONLY INFLATING ON ONE SIDE.

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

  MAUDE report 8374199 ↗
• MalfunctionFeb 26, 2019Inflation Problem; Difficult to Remove; Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO REMOVE AFTER THE SALINE WAS WITHDRAWN FROM THE BALLOON. THE CATHETER WAS REMOVED BY USING A LUBRICANT AND MANUAL MANIPULATION. THE PATIENT VOIDED AFTER THE REMOVAL WITHOUT DIFFICULTY. ONCE REMOVED, THE NURSE TRIED TO FILL THE BALLOON AGAIN WITH SALINE AND NOTICED THE BALLOON WAS ONLY INFLATING ON ONE SIDE.

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

  MAUDE report 8371905 ↗