Bardex® Urethral Catheter Robinson Model 056110Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741033506), received between Jan 14, 2022 and Feb 20, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Flaked” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗