Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 0170SI12Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741025327), received between Aug 21, 2018 and Dec 23, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CUSTOMER HAS RECENTLY EXPERIENCED ISSUES WITH SEVERAL SIZES OF THE FOLEY CATHETERS. THE PART NUMBERS AND LOTS ARE AS FOLLOWS: 0170SI16 - LOT # NGKP4358 X12, 0170SI12 -LOT# NGKS1584 X1 AND 0170SI14 -LOT # NGKU4004. X3. PATIENT WENT TO (B)(6) EMERGENCY ROOM DUE TO FOLEY CATHETER COMING OUT ON (B)(6) 2025. NEW FOLEY CATHETER WAS PLACED AT (B)(6) EMERGENCY ROOM. PATIENT THEN CAME TO (B)(6) EMERGENCY ROOM ON (B)(6) 2025, DUE TO SIMILAR ISSUE CATHETER FALLING OUT (PER PATIENT HEARD HISSING SOUND THEN CATHETER CAME OUT). NEW CATHETER WAS PLACED 14 FRENCH COUDE. ON (B)(6) 2025, PATIENT CAME BACK TO EMERGENCY ROOM DUE TO CATHETER COMING OUT AGAIN AT HOME. ANOTHER NEW 14 FR COUDE WAS PLACED. WHEN PATIENT WAS ABOUT TO LEAVE THE EMERGENCY ROOM, THEY HEARD HISSING SOUND ONCE AGAIN AND CATHETER CAME OUT. ANOTHER NEW 14 FR COUDE WAS PLACED. THIS CATHETER LASTED TILL (B)(6) 2025, CATHETER CAME OUT ONCE AGAIN. DUE TO ISSUES WITH 14 FR COUDE CATHETER SILICONE, THEY PLACED A 16 FR COUDE SILICONE IN HOPES SAME ISSUE DOESN'T OCCUR AGAIN. NOT EVEN 24 HOURS LATER ON DECEMBER 6TH PATIENT CAME BACK FOR CATHETER ONCE AGAIN COMING OUT. DUE TO ISSUES WITH SILICONE CATHETERS OPTED TO P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882712 ↗
• MalfunctionNov 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE FOLEY BALLOON RUPTURED WHILE IN BLADDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23571110 ↗
• MalfunctionMar 1, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THEY FOUND BLACK PARTICLE INSIDE THE FOLEY CATHETERS. IMPACTED PRODUCT AS FOLLOWS - THEY WERE FOUND PRIOR TO PATIENT USE AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815864 ↗
• MalfunctionJun 9, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER HAD TWO PRODUCTS THAT WERE NOT WORKING, AND THE FOLEY CATHETERS WERE BOTH FROM THE SAME LOT. THEY BOTH HAD PARTS OF THE TUBE THAT SEEMED TO BE PINCHED OR BROKEN WHEN THEY WERE REMOVED FROM THE PACKAGE, MAKING THEM UNABLE TO USE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097771 ↗
• MalfunctionJun 5, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING WAS SPLIT JUST ABOVE THE COUDE TIP CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059472 ↗
• MalfunctionSep 20, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THERE WAS A THIN DARK LINE AROUND THE CIRCUMFERENCE OF THE CATHETER INSIDE. PER NOTIFICATION RECEIVED FROM THE INVESTIGATOR VIA EMAIL ON 27AUG2021 BASED ON THE SAMPLE EVALUATION A FLASH WAS FOUND IN THE CATHETER TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12496974 ↗
• MalfunctionAug 31, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE COUDE TIP CATHETER WERE CRACKED. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391483 ↗
• MalfunctionDec 15, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE IS A THIN DARK LINE AROUND THE CIRCUMFERENCE OF THE CATHETER ON THE INSIDE. PER NOTIFICATION ON (B)(6) 2021, FLASH WAS FOUND ON THE CATHETER TIP BASED ON THE SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11012443 ↗
• MalfunctionNov 20, 2020Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THERE WAS DARK MATTER IN THE EYELETS OF THE FOLEY CATHETER WHEN REMOVED FROM THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10876876 ↗
• MalfunctionJul 17, 2020Contamination /Decontamination Problem; Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WERE BLEMISHES INSIDE THE CATHETER AND WAS CONCERNED ABOUT THE STERILITY.

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

  MAUDE report 10288844 ↗
• MalfunctionMay 27, 2020Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO OF THE FOLEY CATHETERS HAD BLACK SPECKS ON THE INSIDE.

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

  MAUDE report 10092236 ↗
• MalfunctionMar 11, 2020Contamination; Material Discolored; Material Discolored

  IT WAS REPORTED THAT UPON OPENING THE CATHETER, THERE WAS A BLACK SPOT NOTICED INSIDE OF THE HOSE. IT WAS STATED THAT THE BLACK SPOT WAS THE SIZE OF A SMALL DOT. THE CUSTOMER DID NOT USE THE PRODUCT.

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

  MAUDE report 9819944 ↗
• MalfunctionAug 21, 2018Break; Material Separation; Break

  IT WAS REPORTED THAT THE TIP OF THE CATHETER SEPARATED FROM THE BALLOON UPON REMOVAL OF THE CATHETER. AT THIS TIME IT IS UNKNOWN IF ANY PIECES OF THE CATHETER WERE LEFT BEHIND. PER FOLLOW UP WITH THE PATIENT BY PHONE ON (B)(6) 2018 IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED BLADDER IRRITATION AND HAS NOT CONTACTED A PHYSICIAN AT THIS TIME. THERE HAS BEEN NO MEDICAL INTERVENTION.

  Patient problems: Irritation

  MAUDE report 7800571 ↗