Bardia 123618CERecalls & 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 00801741171796), received between Jul 23, 2020 and Dec 3, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Infuse” (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
- Failure to Infuse1
- Inflation Problem1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER DRAINAGE LUMEN WAS DAMAGED AND LEAKED AT THE JOINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23708933 ↗MalfunctionJul 23, 2020Inflation Problem; Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THERE WAS A RESISTANCE WHEN ATTEMPTING TO INFLATE THE CATHETER BALLOON WITH WATER. SUPPOSEDLY, THE HUB OF THE INFLATED PART OF THE CATHETER KEPT FILLING INSTEAD OF FILLING THE BALLOON AT THE END OF THE CATHETER INSIDE THE PATIENT. THEREFORE, THE CATHETER WAS REMOVED FROM THE PATIENT AND A NEW 18FR FOLEY CATHETER WAS INSERTED WITH NO ISSUES.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 10316498 ↗
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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