Bardex® Silicone Coated Foley Catheter 0165V16SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741039393), received between Dec 11, 2020 and Nov 25, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 23648979 ↗
• MalfunctionJan 25, 2023Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER HAD TWO FOLEY CATHETERS THAT HAVE HAD HOLES IN THEM. PER FOLLOW UP RECEIVED ON 20JAN2023, CUSTOMER STATED THAT THE BALLOON WOULD NOT HOLD FLUID BECAUSE IT HAD A HOLE. THEY THREW BOTH OF THEM AWAY BECAUSE THEY COULD NOT USE THEM AND NOW DON'T HAVE ENOUGH TO GET THEM TO NEXT SHIPMENT. PER FOLLOW UP VIA PHONE ON 18APRIL2023, IT WAS REPORTED THAT CUSTOMER NO LONGER HAVE THAT INFORMATION AND HAD SINCE THROWN ALL OF THAT INFORMATION AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241985 ↗
• MalfunctionDec 11, 2020Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE TWO CATHETERS WERE CLOGGED. THE FIRST ONE WAS IN EARLY NOVEMBER AND SECOND ONE WAS ON (B)(6) 2020. PER CUSTOMER VIA PHONE ON 18NOV2020 THE CUSTOMER STATED THAT THE CATHETER WAS IN PLACE FOR ABOUT 3 DAYS WHEN THE PATIENT STARTED FEELING THE PAIN AND SOME PRESSURE. THE CUSTOMER NOTICED THE CATHETER WAS CLOGGED AND BADLY DRAINED WHICH CAUSED THE PAIN AND PRESSURE. NO MEDICAL INTERVENTION WAS REQUIRED HOWEVER THE PATIENT HAD TO KEEP THE CATHETER IRRIGATED TO GET IT DRAIN.

  Patient problems: Pain

  MAUDE report 10991835 ↗
• MalfunctionDec 11, 2020Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE TWO CATHETERS WERE CLOGGED. THE FIRST ONE WAS IN EARLY NOVEMBER AND SECOND ONE WAS ON 15NOV2020. PER CUSTOMER VIA PHONE ON (B)(6) 2020 THE CUSTOMER STATED THAT THE CATHETER WAS IN PLACE FOR ABOUT 3 DAYS WHEN THE PATIENT STARTED FEELING THE PAIN AND SOME PRESSURE. THE CUSTOMER NOTICED THE CATHETER WAS CLOGGED AND BADLY DRAINED WHICH CAUSED THE PAIN AND PRESSURE. NO MEDICAL INTERVENTION WAS REQUIRED HOWEVER THE PATIENT HAD TO KEEP THE CATHETER IRRIGATED TO GET IT DRAIN.

  Patient problems: Pain

  MAUDE report 10991828 ↗