Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816Recalls & reported problems

Summary

The FDA's MAUDE database contains 476 adverse event reports that list this exact device (DI 00801741034169), received between Apr 19, 2017 and Sep 28, 2026 — classified as 48 injuries, 428 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (93 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 476 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926179 ↗
• MalfunctionSep 28, 2026Material Rupture

  It was reported that small puncture in catheter near connecting end resulting in continuous urine leakage. Balloon burst resulting in catheter falling out. Potentially dangerous situation because high risk of autonomic dysreflexia. Catheter only changed one day previously. Re-catheterised with different model catheter.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916264 ↗
• MalfunctionJul 15, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25833865 ↗
• MalfunctionJun 27, 2026Material Rupture

  IT WAS REPORTED THAT THE FOLEY BALLOON BROKE AFTER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25646120 ↗
• MalfunctionJun 5, 2026Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON EXPLODED WHEN INFLATED. CUSTOMER UNSURE IF THIS HAPPENED PRIOR TO FOLEY INSERTION OR AFTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410455 ↗
• MalfunctionJun 5, 2026Material Rupture

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON EXPLODED WHEN INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410444 ↗
• MalfunctionMay 27, 2026Inaccurate Flow Rate; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NURSING NOTED URINE LEAKING AROUND THE BALLOON OF THE FOLEY CATHETER, IT WAS REMOVED BY STAFF DUE TO NOT WORKING PROPERLY. FOLEY CATHETER WAS PLACED DUE TO PATIENT HAVE A CESAREAN SECTION; PATIENT WAS ABLE TO VOID ON HER OWN 4 HOURS POST REMOVAL OF FOLEY CATHETER. THERE WAS NO PATIENT HARM. SAMPLE WAS NOT SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25307162 ↗
• MalfunctionMay 22, 2026Component Missing; Component Misassembled

  IT WAS REPORTED THAT 1 OF THE 3 CATHETERS SUPPLIED WAS FAULTY AS THE TIP OF THE CATHETER, THE PART THAT IS INSERTED INTO THE BODY WAS MISSING, IT APPEARED TO BE A MANUFACTURING ISSUE, AS THE MOULD LOOKED DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260346 ↗
• MalfunctionMay 20, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT ADVISED THE FOLEY CATHETER HAD BEEN CHANGED TWICE RECENTLY MOST RECENT LAST THURSDAY WITH LOT NO: NGKU4115 AS THE BALLOON IN THE CATHETER KEEPS SPLITTING AND DEFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25234652 ↗
• MalfunctionMay 6, 2026Material Rupture

  IT WAS REPORTED THAT TUBING ABOVE UROMETER BAG WAS KINKED, INHIBITING THE PROPER FREE FLOW OF URINE. HAS BEEN NOTED ON PLUS FOLEY CATHETER (LOT NGKW1964) AND BALLOON RUPTURED INSIDE PATIENT, ISOLATED TO ONE REPORT (LOT NGLN3869). THESE CATHETER TRAYS WERE STOCKED AT THEIR LOCAL WAREHOUSE. NOT SURE IF THEY SHOULD ISOLATE THE LOT WITH THE KINK SINCE THAT MIGHT BE MORE WIDESPREAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25106782 ↗
• MalfunctionMay 5, 2026Calcified

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS DISCONNECTED FROM THE DRAINAGE BAG WHILE THE RED SEAL WAS STILL IN PLACE. PATIENT WAS ALREADY AT RISK FOR UTI AS SEDIMENT HAS BEEN BUILDING IN THE FOLEY. THE BREAK IN THE FOLEY RAISES EVEN MORE CONCERN THAT PATIENT WAS EXPOSED TO BACTERIA CAUSING INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088833 ↗
• MalfunctionApr 21, 2026Material Twisted/Bent

  IT WAS REPORTED THAT CUSTOMER HAS ADVISED THAT THE LAST 3 CATHETERS, THE TIP IS COMPLETELY BENT, THE PRODUCT CODE: D175816E, LOT NUMBER: MYKU1181, NO AFFECTED: 3 SAMPLES AVAILABLE: NO ¿ IMAGES WILL BE SENT ONCE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941095 ↗
• MalfunctionApr 17, 2026Material Puncture/Hole

  IT WAS REPORTED THAT BALLOON ON FOLEY CATHETER LEAKED DOWN AND CAME OUT OF PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24917986 ↗
• MalfunctionApr 14, 2026Inflation Problem

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON ONLY INFLATED A SMALL AMOUNT. RESISTANCE WAS FELT; TUBING ADJUSTED AND STILL WOULD NOT INFLATE. ATTEMPTED SIZE OF A SMALL BLUEBERRY ONLY TO ONE SIDE. EVEN OUTSIDE OF THEIR BODY THE BALLOON WOULD NOT INFLATE OR DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879375 ↗
• MalfunctionApr 14, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD ADVISED THAT TWO OF THE FOLEY CATHETERS FAILED AS THE BALLOON BURST WHEN FILLED. ALL CATHETERS HAD THE SAME LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24879368 ↗
• MalfunctionApr 1, 2026Difficult to Remove

  IT WAS REPORTED THAT THE URINARY FOLEY CATHETER WAS NOT ABLE TO BE REMOVED AFTER DEFLATING THE BALLOON, DESPITE REMOVING SALINE FROM PORT. THE FOLEY STAYED PUT WHEN GENTLE TRACTION WAS PLACED IN ATTEMPTS TO REMOVE IT. THE TUBING TO THE PORT WAS THEN CUT, AND THE BALLOON DRAINED AND THE CATHETER WAS REMOVED. PRODUCT NUMBERS THAT WERE ON THE PORT WAS: 175816 NGK21906 AND IT WAS A 16 FR. UNABLE TO VERIFY PRODUCT IDENTIFIERS AS THIS WAS PLACED OVER 24 HOURS AGO AND PACKAGING WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758835 ↗
• MalfunctionMar 19, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT HAD A FOLEY CATHETER INSERTED PRIOR TO CESAREAN SECTION. URINE DRAINED IN COLLECTION BAG. WHEN THE SURGERY WAS COMPLETED AND THE BLANKET WAS PULLED BACK, THE FOLEY TUBING AND BULB WERE FOUND TO BE LAYING ON THE BED BETWEEN THE PATIENT'S LEG, COMPLETELY OUT OF THE URETHRA. WHEN THE NURSE TRIED TO BLOW UP THE BALLOON AGAIN WITH WATER THERE WAS A SMALL HOLE WHERE THE WATER WAS LEAKING. PER FOLLOW-UP INFORMATION RECEIVED VIA EMAIL ON 12MAR2026, BOTH PRODUCTS ARE AVAILABLE. FOLEY CATHETER WAS REPLACED. NO TROUBLESHOOTING WAS DONE AS BOTH HAD LEAKS THAT WERE NOT REPAIRABLE. THE LOT #NGKR2507 AND NGKW1965.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24644396 ↗
• MalfunctionMar 13, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A CATHETER HAD BEEN PLACED ON A PATIENT AND HAD FALLEN OUT 10¿12 HOURS AFTER INSERTION, ACCORDING TO THE PATIENT. INITIAL PLACEMENT WAS BELIEVED TO HAVE BEEN SUCCESSFUL, AS THE DEVICE HAD DRAINED APPROPRIATELY INTO A LEG BAG DURING THE DAY FOLLOWING INSERTION. SINCE THE DEVICE HAD FUNCTIONED AS INTENDED AT FIRST, QUESTIONS AROSE REGARDING A POSSIBLE ISSUE WITH THE CATHETER, SUCH AS A SLOW LEAK AFTER BALLOON INFLATION OR A POTENTIAL VALVE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24599051 ↗
• MalfunctionMar 13, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD PRESENTED AT THE HOMECARE OFFICE WITH THE FOLEY CATHETER IN HAND. THEY STATED THAT THE CATHETER HAD BEEN BOTHERING THEM SINCE IT HAD BEEN INSERTED ON WEDNESDAY. ON THE DAY OF THE REPORT, THEY HEARD A LOUD POP BUT WAS UNSURE WHERE IT HAD COME FROM. SHORTLY AFTERWARD, WHEN THEY WENT TO USE THE TOILET, THEY NOTICED THAT THE CATHETER HAD FALLEN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24596015 ↗
• MalfunctionMar 2, 2026Material Puncture/Hole

  IT WAS REPORTED THAT A FOLEY CATHETER HAD BEEN INSERTED POSTOPERATIVELY FOR URINARY RETENTION. AFTER THE BALLOON OF THE CATHETER HAD BEEN INFLATED WITH STERILE WATER, THE CATHETER DID NOT REMAIN IN PLACE. THE FOLEY WAS REMOVED, AND IT WAS FOUND THAT ONLY HALF OF THE BALLOON HAD INFLATED WITH STERILE WATER. THE FOLEY CATHETER HAD TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484435 ↗
• MalfunctionFeb 26, 2026Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON BURST INSIDE THE PATIENT UPON INFLATION WITHOUT KNOWLEDGE UNTIL END OF CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24464307 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak

  IT WAS REPORTED BY THE PATIENT STATED THAT THE FOLEY CATHETER HAD BEEN LEAKING AT THE BAG CONNECTION AND THE DRAINAGE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422032 ↗
• MalfunctionFeb 19, 2026Deflation Problem

  IT WAS REPORTED THAT THE BARD FOLEY CATHETER KIT (16 FRENCH) BALLOON HAD BEEN DIFFICULT TO INFLATE AND DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388973 ↗
• MalfunctionFeb 19, 2026Inflation Problem

  IT WAS REPORTED THAT THE BARD FOLEY CATHETER KIT (16 FRENCH) BALLOON HAD BEEN DIFFICULT TO INFLATE AND DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388786 ↗
• MalfunctionFeb 18, 2026Inflation Problem

  IT WAS REPORTED THAT THEY HAD AN ISSUE WITH THE BARD 16 FRENCH FOLEY CATHETER KIT. THE BALLOON DID NOT WANT TO INFLATE OR DEFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380804 ↗