Bardex® Urethral Catheter Robinson Model 056112Recalls & reported problems
C. R. Bard, Inc. · Bardex® Urethral Catheter Robinson Model · Class 2
All models of Bardex Urethral Catheter Robinson Model (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741033513), received between Jun 7, 2018 and Aug 14, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Degraded” (5 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.
Reports received per month
Most reported problems
Device problems
- Degraded5
- Crack2
- Defective Device2
- Component Missing1
- Manufacturing, Packaging or Shipping Problem1
- Material Integrity Problem1
- Out-Of-Box Failure1
Patient problems
- No Known Impact Or Consequence To Patient5
- No Patient Involvement5
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2024Component Missing; Component Missing
IT WAS REPORTED THAT BARD URETHRAL CATHETERS WERE MISSING FROM THE INDIVIDUAL PACKING WITH BOTH ENDS WERE SEALED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19982740 ↗MalfunctionJan 7, 2020Degraded; Manufacturing, Packaging or Shipping Problem; Degraded
IT WAS REPORTED THAT THE ROBINSON CATHETER APPEARED DATED/DRY IN THE PACKAGING. THE PACKAGING WAS REPORTEDLY "OPENED AND CAUGHT BY ST THAT IT APPEARED OUTDATED." THE EXPIRATION DATE ON THE CATHETER WAS 31MAR2023.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9559856 ↗MalfunctionJan 7, 2020Degraded; Defective Device; Degraded
IT WAS REPORTED THAT THE ROBINSON CATHETER APPEARED DATED/DRY IN THE PACKAGING. THE PACKAGING WAS REPORTEDLY "OPENED AND CAUGHT BY ST THAT IT APPEARED OUTDATED." THE EXPIRATION DATE ON THE CATHETER WAS 31AUG2022.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9559670 ↗MalfunctionJan 7, 2020Degraded; Defective Device; Degraded
IT WAS REPORTED THAT THE ROBINSON CATHETER APPEARED DATED/DRY IN THE PACKAGING. THE PACKAGING WAS REPORTEDLY "OPENED AND CAUGHT BY ST THAT IT APPEARED OUTDATED." THE EXPIRATION DATE ON THE CATHETER WAS 31AUG2022.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 9559516 ↗MalfunctionJun 8, 2018Crack; Degraded; Out-Of-Box Failure; Material Integrity Problem; Degraded
IT WAS REPORTED THAT THE CATHETERS WERE CRACKED AND CRUMBLING WITHIN THE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7582294 ↗MalfunctionJun 7, 2018Crack; Degraded; Degraded
IT WAS REPORTED THAT THE CATHETERS WERE CRACKED AND CRUMBLING WITHIN THE PACKAGING.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 7580326 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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