Bardia® Foley Catheter Silicone Coated 123626ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741095245), received between Jun 30, 2020 and Oct 22, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT HAD A CRANIOCEREBRAL INJURY AND WAS ADMITTED TO THE HOSPITAL FOR BEDSIDE TREATMENT TO MONITOR THE 24HOURS IN AND OUT, AND A URINARY FOLEY CATHETER WAS PLACED, BUT THE CATHETER BALLOON WAS FOUND TO BE BROKEN AND LEAKED, AND THE CATHETER WAS REPLACED WITH ANOTHER CATHETER AND REINTRODUCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507695 ↗
• MalfunctionJun 29, 2022Missing Information; Missing Information

  IT WAS REPORTED THAT NEW MATERIAL CODE OF BARDIA FOLEY CATHETERS DID NOT HAVE COLOR CODING ON THE PACKAGING OF THE BOX AND ALSO THE WORDINGS ON THE INDIVIDUAL STERILE PACKAGING WAS TOO SMALL. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 16JUN2022, CONFIRMED THAT ONE MORE LOT NUMBER OF BARDIA FOLEY CATHETERS DID NOT HAVE COLOR CODING ON THE PACKAGING OF THE BOX AND THE WORDINGS ON THE INDIVIDUAL STERILE PACKAGING WAS TOO SMALL BASED ON THE PHOTO SAMPLE RECEIVED ON 09JUN2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852895 ↗
• MalfunctionJun 27, 2022Illegible Information; Illegible Information

  .IT WAS REPORTED THAT NEW MATERIAL CODE OF BARDIA FOLEY CATHETERS DID NOT HAVE COLOR CODING ON THE PACKAGING OF THE BOX (LOT# MYGN0175, LOT# MYCRRC36 AND LOT# MYFV2209 ) AND THE WORDINGS ON THE INDIVIDUAL STERILE PACKAGING WAS TOO SMALL (LOT# MYGN0175 , LOT# MYCRRC36 AND LOT# MYFV2209 ). PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 16JUN2022, CONFIRMED THAT ONE MORE LOT NUMBER OF BARDIA FOLEY CATHETERS DID NOT HAD COLOR CODING ON THE PACKAGING OF THE BOX (LOT# MYEV2144 - ) AND THE WORDINGS ON THE INDIVIDUAL STERILE PACKAGING WAS TOO SMALL (LOT# MYEV2144 - ) BASED ON THE PHOTO SAMPLE RECEIVED ON 09JUN2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14836278 ↗
• InjuryMar 7, 2021Patient-Device Incompatibility; Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL TWICE AND CURRENTLY HAS URINARY TRACT INFECTION AND RECEIVED TWO DIFFERENT ANTIBIOTICS TO CLEAR UP THE INFECTION. NO PRODUCT ALLEGATION WAS MENTIONED.

  Patient problems: Urinary Tract Infection

  MAUDE report 11429727 ↗
• MalfunctionFeb 25, 2021Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THERE WAS A BALLOON RUPTURE IN THE CATHETER AND STATED THAT CUSTOMER USED ANOTHER CATHETER.

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

  MAUDE report 11378737 ↗
• MalfunctionJun 30, 2020Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER BALLOON POPPED.

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

  MAUDE report 10215142 ↗