Bardex® Silicone Coated Foley Catheter 0165V18SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741039409), received between May 13, 2021 and Sep 25, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Inaccurate Flow Rate” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Inaccurate Flow Rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903531 ↗
• MalfunctionMar 7, 2026Material Puncture/Hole

  THE PATIENT WAS ADMITTED TO THE DEPARTMENT OF RESPIRATORY AND CRITICAL CARE MEDICINE ON (B)(6) 2026, PRESENTING WITH COUGH AND PHLEGM PRODUCTION FOR OVER ONE MONTH. A URINARY FOLEY CATHETER WAS REPLACED ON THE DAY OF ADMISSION. AROUND 19:10 ON (B)(6) 2026, THE CATHETER SPONTANEOUSLY DISLODGED, CAUSING URINE LEAKAGE. THE PHYSICIAN REINSERTED THE CATHETER. DURING THE AFTERNOON SHIFT, THE NURSE INFLATED THE CATHETER'S WATER BALLOON AND SUBMERGED IT IN A CUP OF WATER. SMALL BUBBLES WERE OBSERVED RISING, THOUGH NO VISIBLE TEAR WAS DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539943 ↗
• MalfunctionJan 26, 2026Material Puncture/Hole

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT URETEROSCOPY LITHOTRIPSY ON (B)(6) 2025. AT 7:50 AM ON (B)(6) 2025, WHILE DEFECATING, THE PATIENT FELT THE URINARY FOLEY CATHETER SLIP OUT AND NOTICED URINE OVERFLOWING FROM THE URETHRAL OPENING. THE CATHETER WAS OBSERVED TO HAVE DISLODGED FROM THE URETHRA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185530 ↗
• MalfunctionNov 26, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ONE PACKAGE OF 8 URINARY CATHETERS CONTAINED SHREDDED PAPE N(LOT#MYGV4245- OCCURENCE-3), (LOT#MYGY4017, OCCURENCE-3) , 1(LOT#MYHW3462, OCCURENCE-1)]", (LOT#MYHT0905, OCCURENCE-1)]" AND ONE PRODUCT EXHIBITED AIR LEAKAGE (LOT#MYGV4245- OCCURENCE-1).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657706 ↗
• MalfunctionNov 25, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT ONE PACKAGE OF 8 URINARY CATHETERS CONTAINED SHREDDED PAPER (LOT#MYGV4245- OCCURENCE-3), (LOT#MYGY4017, OCCURENCE-3)]" , (LOT#MYHW3462, OCCURENCE-1), (LOT#MYHT0905, OCCURENCE-1) AND ONE PRODUCT EXHIBITED AIR LEAKAGE (LOT#MYGV4245- OCCURENCE-1).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649284 ↗
• MalfunctionJun 29, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT INFLATE. ALSO, CUSTOMER STATED THAT NO URINE RETURNED, AND TIP OF THE CATHETER WAS BROKEN.

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

  MAUDE report 14854230 ↗
• MalfunctionJun 29, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT INFLATE. ALSO, CUSTOMER STATED THAT NO URINE RETURNED, AND TIP OF THE CATHETER WAS BROKEN.

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

  MAUDE report 14853676 ↗
• MalfunctionJun 29, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT INFLATE. ALSO, CUSTOMER STATED THAT NO URINE RETURNED, AND TIP OF THE CATHETER WAS BROKEN.

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

  MAUDE report 14853435 ↗
• MalfunctionJun 29, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT INFLATE. ALSO, CUSTOMER STATED THAT NO URINE RETURNED, AND TIP OF THE CATHETER WAS BROKEN.

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

  MAUDE report 14853299 ↗
• MalfunctionJun 29, 2022Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT INFLATE. THE CUSTOMER STATED THAT NO URINE RETURNED, AND THE TIP WAS BROKEN.

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

  MAUDE report 14852649 ↗
• MalfunctionJun 28, 2022Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON DID NOT INFLATE. ALSO, CUSTOMER STATED THAT NO URINE RETURNED, AND TIP OF THE CATHETER WAS BROKEN.

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

  MAUDE report 14841749 ↗
• MalfunctionMay 13, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CATHETER WAS INSERTED PRIOR TO THE SURGICAL BLADDER PROCEDURE FOR DIVERTICULUM REMOVAL. ONCE THE BLADDER WAS OPENED BY REMOVAL OF THE DIVERTICULUM, THE CATHETER TIP WAS MISSING.

  Patient problems: Foreign Body In Patient

  MAUDE report 11820055 ↗