Bardex® Lubri-Sil® All-Silicone Foley Catheter 73022LRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00801741034329), received between Jan 2, 2019 and Sep 16, 2025 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (10 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FOLEY CATHETER WAS BEING USED DURING A TURP AND WAS FOUND TO DRIP AT THE JUNCTION BETWEEN THE TUBE AND THE 3 WAYS. THEY WOULD LIKE THIS ESCALATED AS THE SAID IT WAS NOT THE FIRST TIME THIS HAD HAPPENED USING THIS TYPE OF CATHETER, BUT THIS WAS THE FIRST TIME THEY HAD REPORTED IT TO THEM FOR ESCALATION OR PROVIDED EVIDENCE. PER NOTIFICATION FROM UCC ON 02FEB2026, IT WAS REPORTED THAT BALLOON MUSHROOMED WAS FOUND DURING SAMPLE EVALUATION ON 14OCT2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23064993 ↗
• MalfunctionSep 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE IN THE FOLEY CATHETERS. MULTIPLE CATHETERS FROM THE SAME LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937301 ↗
• MalfunctionAug 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT CUSTOMER RECEIVED SOME FAULTY CATHETERS. IT WAS A 3-WAY CATHETER, AND THE END THAT WAS CONNECTED TO THE URINE BAG LEAKED URINE, DISTAL TO THE END HOLE WHERE THE USER INSERTED THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714572 ↗
• MalfunctionNov 22, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE 3-WAY FOLEY CATHETER BEGAN TO IRRIGATE, UPON IRRIGATION A HOLE IN THE FOLEY TUBING WAS NOTED. FOLEY HAD TO BE REMOVED AND A NEW ONE WAS PLACED AND THE ITEM WAS DEFECTIVE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758214 ↗
• MalfunctionApr 1, 2024Material Invagination; Material Invagination

  IT WAS REPORTED THAT WHILE DEFLATING THE FOLEY CATHETER BALLOON, A RING OR RIDGE WAS CREATED WHICH CAUSED PAIN TO THE PATIENT DURING REMOVAL. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 19011268 ↗
• MalfunctionMar 24, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A HOLE JUST DISTAL TO THE THREE-WAY PORT OF THE FOLEY CATHETER, SO THE IRRIGANTS WERE SQUIRTING OUT. STATED THAT THE SAMPLE WAS NOT AVAILABLE SINCE IT WAS WITH THE PATIENT, AND IT WAS DISCARDED. AS PER FOLLOW UP VIA EMAIL RECEIVED ON 03FEB2023, IT WAS STATED THAT THEY HAD THREE INCIDENTS AT THE HOSPITAL WHERE 22FRENCH SILICON 3 WAYS CATHETERS WERE PLACED. ONCE THE CBI WAS STARTED IT WAS NOTICED THAT WATER WAS GUSHING OUT OF THE SIDES DUE TO A HOLE. IN TERMS OF IMPACT, THE HOLE IN THE CATHETER WOULD BREAK STERILITY. IT WAS ALSO STATED THAT IT WAS PAINFUL FOR PATIENTS TO HAVE CATHETERS REPLACED ESPECIALLY ONE AS LARGE AS A 22FRENCH CATHETERS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 03MAR2023, IT WAS REPORTED THAT THE ANOTHER CATHETER WITH A HOLE WAS FOUND TODAY. THEY CURRENTLY HAD 8 AND A HALF BOXES FULL OF 22FR SILICON 3 WAY CATHETERS AND THEY WERE NO LONGER FEEL COMFORTABLE USING THESE CATHETERS. THE HOLE WAS SMALL AND ON THE THIRD PORT SECTION OF THE TUBE AND VERY DISTAL AND JUST PROXIMAL TO THE BIFURCATION AND ONLY SEE THE HOLE ONCE THE CBI IRRIGANT WAS TURNED ON AND IT SQUIRTS OUT. IN TERMS OF PATIENT CARE, EXCHANGING THE CATHETER WAS PAIN

  Patient problems: Discomfort; Pain

  MAUDE report 16610607 ↗
• MalfunctionFeb 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A HOLE JUST DISTAL TO THE THREE-WAY PORT OF THE FOLEY CATHETER, SO THE IRRIGANTS WERE SQUIRTING OUT. STATED THAT THE SAMPLE WAS NOT AVAILABLE SINCE IT WAS WITH THE PATIENT, AND IT WAS DISCARDED. PER FOLLOW UP VIA EMAIL RECEIVED ON 03-FEB-2023, IT WAS STATED THAT THEY HAD THREE INCIDENTS AT THE HOSPITAL WHERE 22FRENCH SILICON 3 WAYS CATHETERS WERE PLACED. ONCE THE CBI WAS STARTED IT WAS NOTICED THAT WATER WAS GUSHING OUT OF THE SIDES DUE TO A HOLE. IN TERMS OF IMPACT, THE HOLE IN THE CATHETER WOULD BREAK STERILITY. IT WAS ALSO STATED THAT IT WAS PAINFUL FOR PATIENTS TO HAVE CATHETERS REPLACED ESPECIALLY ONE AS LARGE AS A 22FRENCH CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363433 ↗
• MalfunctionMay 4, 2022Illegible Information; Illegible Information

  IT WAS REPORTED THAT OUR WAREHOUSE RECEIVED INCOMING SHIPMENT WITH ONE BOX OF STOCK WITH A DEFACED LABEL. IT WAS NOT SENT OUT TO AN AUSTRALIAN CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14280826 ↗
• MalfunctionSep 27, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER FOUND ONLY 6 EACHES IN THE BOX INSTEAD OF 12 EACHES IN THE FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532950 ↗
• MalfunctionSep 24, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER FOUND ONLY 6 FOLEY CATHETERS IN THE BOX INSTEAD OF 12 FOLEY CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525660 ↗
• MalfunctionSep 24, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER FOUND ONLY 6 FOLEY CATHETERS IN THE BOX INSTEAD OF 12 .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525017 ↗
• MalfunctionSep 23, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER FOUND ONLY 6 FOLEY CATHETERS IN THE BOX INSTEAD OF 12 CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12520128 ↗
• MalfunctionSep 23, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER FOUND ONLY 6 FOLEY CATHETERS IN THE BOX INSTEAD OF 12 CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12520122 ↗
• MalfunctionSep 23, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER FOUND ONLY 6 FOLEY CATHETERS IN THE BOX INSTEAD OF 12 CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12519923 ↗
• MalfunctionJul 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT BARD LUBRISIL FOLEY CATHETER WAS PLACED ON A MALE PATIENT WHO HAD A TRANSURETHRAL RESECTION OF THE PROSTATE WITH LASER. THE DOCTOR INFLATED THE BALLOON AND A STREAM OF WATER SQUIRTED OUT FROM A PREVIOUS UNRECOGNIZABLE TINY HOLE IN THE CATHETER APPROXIMATELY 3 CENTIMETERS FROM WHERE THE BALLOON CHANNEL EXITS THE CATHETER. IT WAS ALSO STATED THAT THE SAME SITUATION OCCURRED IN THE PREVIOUS WEEK AND THE HOLE WAS IN THE EXACT SAME SPOT ON THAT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129858 ↗
• MalfunctionJul 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT BARD LUBRISIL FOLEY CATHETER WAS PLACED ON A MALE PATIENT WHO HAD A TRANSURETHRAL RESECTION OF THE PROSTATE WITH LASER. THE DOCTOR INFLATED THE BALLOON AND A STREAM OF WATER SQUIRTED OUT FROM A PREVIOUS UNRECOGNIZABLE TINY HOLE IN THE CATHETER APPROXIMATELY 3 CENTIMETERS FROM WHERE THE BALLOON CHANNEL EXITS THE CATHETER. IT WAS ALSO STATED THAT THE SAME SITUATION OCCURRED IN THE PREVIOUS WEEK AND THE HOLE WAS IN THE EXACT SAME SPOT ON THAT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129448 ↗
• MalfunctionJul 2, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BALLOON WAS INFLATED AND A STREAM OF WATER SQUIRTED OUT FROM A PREVIOUSLY UNRECOGNIZABLE TINY HOLE IN THE CATHETER, APPROXIMATELY 3CM FROM WHERE THE BALLOON CHANNEL EXITS THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12107722 ↗
• MalfunctionJun 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT SEVERAL CATHETERS HAD AN ISSUE. IT WAS STATED THAT THE CATHETER HAD A HOLE IN IT. PER FOLLOW UP MADE ON 31MAR2021, PICTURE SAMPLE WAS PROVIDED AND IT SHOWED A HOLE IN THE CATHETER WHICH WAS UNABLE TO SEE WITH NAKED EYE. PER ADDITIONAL INFORMATION RECEIVED ON 28MAY2021, CUSTOMER HAD SAME HOLE ISSUE WITH THE SAME LOT NUMBER. ANOTHER CATHETER WAS USED TO FINISH THE CASE. ALSO STATED THAT 5 MORE CATHETERS (UNUSED) WERE AFFECTED FROM THAT LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041011 ↗
• MalfunctionJun 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SEVERAL CATHETERS HAD AN ISSUE. IT WAS STATED THAT THE CATHETER HAD A HOLE IN IT. PER FOLLOW UP MADE ON 31MAR2021, PICTURE SAMPLE WAS PROVIDED, AND IT SHOWED THE HOLE IN CATHETER AND UNABLE TO SAW THE HOLE WITH NAKED EYE. PER ADDITIONAL INFORMATION RECEIVED ON 28MAY2021, CUSTOMER HAD SAME HOLE ISSUE WITH THE SAME LOT NUMBER. ANOTHER CATHETER WAS USED TO FINISH THE CASE. IT WAS ALSO STATED THAT 5 MORE CATHETERS (UNUSED) WERE AFFECTED FROM THAT LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040992 ↗
• MalfunctionMar 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SEVERAL CATHETERS HAD AN ISSUE. IT WAS STATED THAT THE CATHETER HAD A HOLE IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11542685 ↗
• MalfunctionMar 18, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A HOLE WAS FOUND ON THE SHAFT OF THE CATHETER NEAR THE TRIFURCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515265 ↗
• MalfunctionMar 18, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A HOLE WAS FOUND ON THE SHAFT OF THE CATHETER NEAR THE TRIFURCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11515263 ↗
• MalfunctionFeb 25, 2020Inability to Irrigate; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLOW FROM THE 3-WAY SILICONE FOLEY CATHETER, AND THE PHYSICIAN WAS UNABLE TO IRRIGATE THE CATHETER USING A SYRINGE. REPORTEDLY, IT WAS THE SECOND TIME THE INCIDENT HAD OCCURRED.

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

  MAUDE report 9750772 ↗
• MalfunctionFeb 25, 2020Inability to Irrigate; No Flow

  IT WAS REPORTED THAT THERE WAS NO FLOW FROM THE 3-WAY SILICONE FOLEY CATHETER, AND THE PHYSICIAN DR. (B)(6) WAS UNABLE TO IRRIGATE THE CATHETER USING A SYRINGE. REPORTEDLY, THIS WAS THE SECOND TIME THE INCIDENT HAD OCCURRED.

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

  MAUDE report 9750551 ↗
• MalfunctionFeb 24, 2020Inaccurate Flow Rate; Inability to Irrigate; No Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT THERE WAS NO FLOW FROM THE 3-WAY SILICONE FOLEY CATHETER, AND THE PHYSICIAN WAS UNABLE TO IRRIGATE THE CATHETER USING A SYRINGE. REPORTEDLY, IT WAS THE SECOND TIME THE INCIDENT HAD OCCURRED.

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

  MAUDE report 9745454 ↗