Bardia 123612CERecalls & reported problems
C. R. Bard, Inc. · Bardia Silicone Elastomer Coated Foley Catheter · Class 2
All models of Bardia (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741171765), received between Jul 1, 2024 and Jul 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Deflation Problem” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Deflation Problem1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT BEFORE USE, FOLEY CATHETER BALLON COULD NOT BE DEFLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22644024 ↗MalfunctionJul 1, 2024Material Rupture; Material Rupture
IT WAS REPORTED THAT PATIENT (FEMALE, 61 YEARS OLD) ADMITTED YESTERDAY FOR SURGERY WAS DONE FOR LAPAROSCOPY ASSISTED VAGINAL HYSTERECTOMY BILATERAL SALPINGO-OOPHORECTOMY AND PELVIC REPAIR. INDWELLING CATHETER F12 WAS INSERTED BY DOCTOR PRIOR TO SURGERY IN OPERATING ROOM WITH 10MLS OF WATER. TODAY (1ST POST-OP DAY) AT AROUND 13:15 HOURS, SN A ASSISTED PATIENT FOR AMBULATION AND WAS BROUGHT TO TOILET FOR PERINEAL WASH. WHEN STANDING UP AFTER SEATING IN THE TOILET BOWL, THE INDWELLING CATHETER CAME OUT. UPON CLOSER INSPECTION, THE BALLOON WAS TORN. DOCTOR WAS INFORMED AND REINSERTED INDWELLING CATHETER. PATIENT WAS TRANSFERRED TO WARD 5A ON (B)(6) 2024 AT 22:30 HOURS WITH INDWELLING CATHETER TO KEEP TILL REVIEW. DOCTOR MADE ROUNDS ON (B)(6) 2024 11:52 HOURS AND ORDERED TO REMOVE INDWELLING CATHETER. AT 12:00 HOURS, SSN A ATTEMPTED TO DEFLATE BALLOON PRIOR TO REMOVAL BUT CAME OUT SMALL AMOUNT ONLY. NORMALLY, IF SYRINGE WAS INSERTED IN THE PORT, WATER FROM THE BALLOON WILL COME OUT SPONTANEOUSLY BUT THIS TIME IT DID NOT. SO, PATIENT TRIED TO ASPIRATE AND 1.5ML WAS EXTRACTED AND TRIED TO PULL INDWELLING CATHETER BUT RESISTANCE WAS FELT. PATIENT CALLED SSN B TO COME AND CHECK AND ALSO TRI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19642939 ↗
Other CATHETER, UROLOGICAL devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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