Bardex Urethral Catheter Robinson ModelRecalls & reported problems across all models
C. R. Bard, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 8 models of Bardex Urethral Catheter Robinson Model by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Sep 5, 2017 and Apr 7, 2026 — classified as 22 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bardex Urethral Catheter Robinson Model problems
Device problems
- Degraded5
- Flaked4
- Crack3
- Device Contaminated During Manufacture or Shipping3
- Naturally Worn3
- Defective Device2
- Incorrect Measurement2
- Material Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Patient Involvement7
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient1
- No Information1
Bardex Urethral Catheter Robinson Model models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® Urethral Catheter Robinson Model 056110CATHETER, UROLOGICAL7 reports
- Bardex® Urethral Catheter Robinson Model 056112CATHETER, UROLOGICAL6 reports
- Bardex® Urethral Catheter Robinson Model 056118CATHETER, UROLOGICAL3 reports
- Bardex® Urethral Catheter Robinson Model 056108CATHETER, UROLOGICAL2 reports
- Bardex® Urethral Catheter Robinson Model 056032CATHETER, UROLOGICAL1 report
- Bardex® Urethral Catheter Robinson Model 056114CATHETER, UROLOGICAL1 report
- Bardex® Urethral Catheter Robinson Model 056116CATHETER, UROLOGICAL1 report
- Bardex® Urethral Catheter Robinson Model 056122CATHETER, UROLOGICAL1 report
Recent Bardex Urethral Catheter Robinson Model adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026
STAFF OPENED A CATHETER PACKAGE AND NOTICED THAT THE CATHETER MATERIAL APPEARED FADED AND CRACKED. THEY DID NOT USE THE CATHETER AND CHOSE ANOTHER PRODUCT THAT PASSED A VISUAL INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799643 ↗MalfunctionFeb 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THEIR CLINICAL STAFF STATED THAT THEY NOTICED CRACKING IN GENERAL PURPOSE LATEX INTERMITTENT CATHETERS [PCN #277710 (BATCH #UNK), (BATCH #NGFS3051, BATCH #NGHV0932, BATCH #NGGR2390, BATCH #NGGQ3730], [PCN #277708 (BATCH #NGHS3453, BATCH #NGGZ0495, BATCH #NGGT3524,BATCH #NGGY3130, BATCH #NGGS2682)], [PCN #94180 (BATCH #NGEY3152)], [PCN #94120, BATCH #NGEV4510)], [PCN #56110 (BATCH #NGFW2958)], [PCN #56114 (BATCH #NGGV2774)]. THEY WERE CONCERNED THAT THEY WERE BRITTLE AND COULD AFFECT PATIENT SAFETY. BASED OFF OF THEIR CONCERNS, THEY SWEPT THEIR SUPPLY AREAS AND FOUND THE CATHETERS BELOW TO SHOW THE SAME CHARACTERISTICS. THEY WOULD LIKE TO HAVE THOSE EVALUATED. THEY HAVE ALSO INCLUDED A PHOTO BELOW, WHICH SHOWS THE CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21423626 ↗MalfunctionFeb 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THEIR CLINICAL STAFF STATED THAT THEY NOTICED CRACKING IN GENERAL PURPOSE LATEX INTERMITTENT CATHETERS [PCN #(B)(6) (BATCH #UNK), (BATCH #NGFS3051), (BATCH #NGHV0932), (BATCH #NGGR2390), (BATCH #NGGQ3730], [PCN #(B)(6) (BATCH #NGHS3453), (BATCH #NGGZ0495), (BATCH #NGGT3524), (BATCH #NGGY3130), (BATCH #NGGS2682], [PCN #(B)(6) (BATCH #NGEY3152], ]PCN #(B)(6) (BATCH #NGEV4510], [PCN #(B)(6) (BATCH #NGFW2958], [PCN #(B)(6) (BATCH #NGGV2774]. THEY WERE CONCERNED THAT THEY WERE BRITTLE AND COULD AFFECT PATIENT SAFETY. BASED OFF OF THEIR CONCERNS, THEY SWEPT THEIR SUPPLY AREAS AND FOUND THE CATHETERS BELOW TO SHOW THE SAME CHARACTERISTICS. THEY WOULD LIKE TO HAVE THOSE EVALUATED. THEY HAVE ALSO INCLUDED A PHOTO BELOW, WHICH SHOWS THE CRACKING. PER CUSTOMER FOLLOW UP INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2025, STATED THAT THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21410168 ↗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 ↗MalfunctionMay 22, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT CUSTOMER HAD SEVERAL ROBINSON INTERMITTENT CATHETERS ON THEIR SHELF THAT WERE APPEARING TO LOSE COLOR OR BREAK DOWN OR HAD CRACKS AS IN THE ATTACHED PICTURE. THEY ALL SAID THAT THEY HAD 3 YEARS OR MORE YEARS OF SHELF-LIFE LEFT, BUT SURGEONS WERE LEERY TO USE THEM DUE TO THIS BREAK DOWN (LOT#NGJP0217 AND LOT#NGHT0223).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19372270 ↗MalfunctionMay 22, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT CUSTOMER HAD SEVERAL ROBINSON INTERMITTENT CATHETERS ON THEIR SHELF THAT WERE APPEARING TO LOSE COLOR OR BREAK DOWN OR HAD CRACKS AS IN THE ATTACHED PICTURE. THEY ALL SAID THEY HAD 3 YEARS OR MORE YEARS OF SHELF-LIFE LEFT, BUT SURGEONS WERE LEERY TO USE THEM DUE TO THIS BREAK DOWN (LOT#NGJP0217 AND LOT#NGHT0223). PER FOLLOW UP RESPONSE VIA EMAIL ON 22MAY2024, STATED THAT CUSTOMER WOULD NOT USE CATHETERS ON PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19371590 ↗MalfunctionApr 29, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT LOT#NGHY0765 WAS SUPPOSED TO BE 8FR INTERMITTENT CATHETER BUT WHEN COMPARED TO OTHER 8FR WITH DIFFERENT LOT#¿S THESE WERE BIGGER THAN AN 8FR. PER FOLLOW UP VIA EMAIL RESPONSE ON 21MAY2024, IT WAS REPORTED THAT THE DEFECT WAS NOTICED BEFORE USE AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19200518 ↗MalfunctionApr 1, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PACKAGING OF 2 INTERMITTENT CATHETERS WERE RIPPED AND HENCE, THE CATHETERS BECAME UNSTERILE. PER SAMPLE RECEIVED ON 08MAR2022, IT WAS NOTED THAT THE INTERMITTENT CATHETERS WERE RETURNED FOR EVALUATION. PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON 15MAR2022, CUSTOMER STATED THAT THE WRAPPER OF THE INTERMITTENT CATHETERS HAD TEARS WHICH RESULTED IN THE CATHETERS BECOMING UNSTERILE. IT WAS STATED THAT THE SECOND CATHETER HAD THE SAME RESULT AND NO FURTHER ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13980173 ↗MalfunctionMar 9, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PACKAGING OF 2 INTERMITTENT CATHETERS WERE RIPPED AND HENCE, THE CATHETERS BECAME UNSTERILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13710268 ↗MalfunctionJan 19, 2022Flaked; Flaked
IT WAS REPORTED THAT THE LOOSE PARTICULATES WAS COMING OFF FROM THE PACKAGING OF ROBINSON INTERMITTENT CATHETERS. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 10JAN2022, IT WAS REPORTED THAT THE LOOSE PARTICULATES WERE FOUND BY THE MEDLINE PRODUCTION TEAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13290586 ↗MalfunctionJan 14, 2022Flaked; Device Contaminated During Manufacture or Shipping; Flaked; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE ROBINSON INTERMITTENT CATHETER PACKAGING WAS FLAKED OFF ONTO OTHER COMPONENTS INSIDE THE PACK. THE PROVIDED LOTS WERE (NGDZ3241), (NGEZ0776), (NGFN2700).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13259729 ↗MalfunctionJan 14, 2022Flaked; Device Contaminated During Manufacture or Shipping; Flaked; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE ROBINSON INTERMITTENT CATHETER PACKAGING WAS FLAKED OFF ONTO OTHER COMPONENTS INSIDE THE PACK. THE PROVIDED LOTS WERE NGDZ3241, NGEZ077 AND NGFN2700.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13259270 ↗MalfunctionJan 14, 2022Flaked; Device Contaminated During Manufacture or Shipping; Flaked; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE ROBINSON INTERMITTENT CATHETER PACKAGING WAS FLAKED OFF ONTO OTHER COMPONENTS INSIDE THE PACK. THE PROVIDED LOTS WERE NGDZ3241, NGEZ077 AND NGFN2700.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13258949 ↗MalfunctionJul 17, 2020Material Integrity Problem; Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE RED RUBBER CATHETER WAS GETTING BRITTLE OR DRY BEFORE EXPIRATION.
Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement
MAUDE report 10288701 ↗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 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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