Bardex® I.C. Foley Catheter 0165SI16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,052 adverse event reports that list this exact device (DI 00801741016752), received between Mar 29, 2017 and Sep 30, 2026 — classified as 93 injuries, 959 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (169 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 1,052 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952605 ↗
• MalfunctionSep 30, 2026Disconnection

  It was reported that the Foley catheter was leaking and discovered that the collection port was missing. The detached collection port was found on the patient absorbent pad.As per customer follow up information received on 08Sep2026, physical samples are available. There was no medical intervention required.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951862 ↗
• MalfunctionSep 29, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940874 ↗
• MalfunctionSep 29, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940505 ↗
• MalfunctionSep 25, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899366 ↗
• MalfunctionSep 18, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829597 ↗
• MalfunctionSep 18, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819870 ↗
• MalfunctionSep 18, 2026Material Puncture/Hole

  It was reported that during use a balloon catheter was inserted during surgery on (b)(6). It came out spontaneously in the ward on (b)(6). Suspecting a malfunction, the foley catheter balloon was inflated and expanded without issue. There were no abnormalities for about three hours, but six hours later, the balloon had deflated. The area near the tip was wet.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819868 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  It was reported that the Regular catheter was very uncomfortable and got infection. No medical intervention was reported.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 50802928 ↗
• MalfunctionSep 14, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50764413 ↗
• MalfunctionSep 11, 2026Material Puncture/Hole

  It was reported that this was a case of spontaneous dislodgement of the Foley Catheter. On August 31, following placement, while the patient was sitting on the toilet seat in the wheelchair-accessible restroom on September 3, the catheter spontaneously dislodged; therefore, its use was discontinued, and a different device was used for insertion. At the time of dislodgement, the catheter¿s cuff had deflated; although it was inflated with air and expanded, it reportedly continued to deflate even though there was no leakage from the cuff.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50735892 ↗
• MalfunctionSep 2, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573358 ↗
• MalfunctionSep 2, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563774 ↗
• MalfunctionSep 2, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563773 ↗
• MalfunctionAug 28, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50506896 ↗
• MalfunctionAug 28, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50501980 ↗
• InjuryAug 24, 2026Patient Device Interaction Problem

  It was reported that a catheter was placed on (b)(6) for a patient hospitalized in the (b)(6) Department due to a cerebral infarction. It was temporarily removed on (b)(6), but the patient developed urinary retention on (b)(6), and approximately 700 mL of urine was ejected via catheterization. On (b)(6), a Foley catheter was placed, but the patient complained of abdominal pain. A contrast-enhanced CT scan revealed that the catheter had penetrated the bladder wall by approximately 5 cm and was protruding outside the bladder. The patient has developed sepsis due to a urinary tract infection (UTI), which has led to peritonitis.

  Patient problems: Abdominal Pain; Perforation; Urinary Retention

  MAUDE report 50409215 ↗
• MalfunctionAug 6, 2026Material Puncture/Hole; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50166664 ↗
• MalfunctionAug 4, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50131790 ↗
• MalfunctionJul 15, 2026Calcified

  IT WAS REPORTED BY CUSTOMER THAT THEY WERE USING LATEX FOLEY 0165SI16 BUT WAS HAVING ISSUES WITH SEDIMENT SO THEY SWITCHED TO A SILICONE FOLEY: 175816. THEY STATE WHEN LOOKING AT THESE PRODUCTS THE EXTERNAL DIAMETERS LOOK DIFFERENT. THE SILICONE LOOKS A GOOD BIT SMALLER THAN THE LATEX FOLEY. VERBAL RESPONSE NOTES: EXPLAINED THAT THE SILICONE FOLEY SHOULD HAVE A LARGER INTERNAL DIAMETER THAN LATEX, BUT NOT THE OUTER DIAMETER. EXPLAINED HOW 16FR IS; 16FR NO MATTER THE SUBSTRATE. LEAKING CAN BE CAUSED BY A FEW ISSUES. SUGGESTED SPEAKING WITH HIS UROLOGIST TO IDENTIFY THE ROOT CAUSE. EXPLAINED HE CAN DISCUSS A DIFFERENT SIZE WITH HIS HCP, BUT DO NOT RECOMMEND CHANGING WITHOUT DISCUSSING FIRST. THEY HAVE STATED THAT THEY WILL DISCUSS THESE ISSUES WITH THEIR DOCTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25833860 ↗
• MalfunctionJul 14, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25816391 ↗
• MalfunctionJul 7, 2026Fracture

  It was reported via email that during routine care and flushing of a (SP) Foley catheter, a mechanical issue was identified with the catheter flush valve. Staff noticed that the flush port was cracking more frequently during flushing. Due to the malfunctioning valve, the catheter could not be flushed properly, which resulted in several catheters needing to be replaced. We are able to reposition valve plastic some of the time for proper flushing but have had to replace the foley catheter several times.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25736196 ↗
• MalfunctionJun 17, 2026Material Rupture

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON WAS DAMAGED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540152 ↗
• InjuryJun 16, 2026Difficult to Remove

  IT WAS REPORTED THAT THEY RECENTLY ENCOUNTERED A CONCERNING SITUATION WHERE A NURSE WAS UNABLE TO PULL OUT STERILE WATER FROM THE FOLEY CATHETER, OR THE CATHETER BALLOON AND THE FOLEY COULD NOT BE REMOVED. THE PATIENT ULTIMATELY HAD TO BE SENT TO THE HOSPITAL FOR REMOVAL.

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

  MAUDE report 25520745 ↗
• MalfunctionJun 10, 2026Material Puncture/Hole

  IT WAS REPORTED THAT FOLEY CATHETER FELL OUT ON ITS OWN IMMEDIATELY AFTER BEING INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462560 ↗