Bard® Urethral Catheter 120616Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00801741029974), received between Sep 26, 2017 and Jul 9, 2025 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT AFTER BLADDER INSTILLATION THERAPY, WRITER DEFLATED THE BALLOON AND REMOVED 10 MLS OF STERILE WATER. THE CAP SUDDENLY DETACHED FROM THE RED RUBBER CATHETER AND UNABLE TO UNLATCHED THE SYRINGE. UNLATCHED THE SYRINGE AFTER FEW ATTEMPTS OF REMOVAL. INFORMED THE PATIENT WHAT HAPPENED, NO HARM WAS DONE. TREATMENT WAS FINISHED AND PATIENT LEFT UNIT WITH NO VOICED CONCERNS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22458100 ↗
• MalfunctionMar 21, 2025Component Misassembled; Wrong Label; Component Misassembled; Wrong Label

  IT WAS REPORTED THAT MISMARKED SIZING. PACKAGING SATED ONE SIZE BUT WHEN OPENED, THE CATHETERS WERE A DIFFERENT SIZE. SUPPOSED TO BE COUDE TIP AND SOME WERE NOT. NOT THE ENTIRE BOX, MISMATCHED IN THE BOX. CUSTOMER REQUESTED NEED WRONG SIZED AND SHAPED CATHETERS REPLACED. PER FOLLOW UP VIA EMAIL ON 04MAR2025, IT WAS REPORTED THAT CUSTOMER RECEIVED ABOUT 3 OR 4 MIS-SIZED CATHETERS; EACH WAS ONE SIZE LARGER (#18 INSTEAD OF #16) BUT WERE IDENTIFIED IN THE PACKAGING AS THE SMALLER SIZE. CUSTOMER HAVE NOT RECEIVED ANY SUCH MISMARKED CATHETERS SINCE. THE CATHETERS THAT HAD DEFECTIVE COUDE TIPS WERE THE CORRECT SIZE BUT MISSHAPEN TO THE EXTENT THAT THE TIPS HAD A VERY MINIMAL COUDE CURVE THAT WAS CONSIDERABLY SHALLOWER THAN NORMAL, AND THEREFORE UNUSABLE. CUSTOMER HAVE RETAINED A COUPLE OF SUCH CATHETERS. THEY WOULD ADD THAT THEY HAD ALSO RECEIVED SEVERAL CATHETERS WHOSE LENGTH, INSTEAD OF BEING STRAIGHT, WERE S-SHAPED AND/OR TWISTED. HOWEVER, NONE OF THESE DEFECTS HAVE APPEARED IN THEIR LATEST SHIPMENT. IN NO CASES HAVE I BEEN HARMED OR INJURED BY CATHETERS, ONLY INCONVENIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662948 ↗
• MalfunctionFeb 25, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT PRODUCT WAS DEFECTIVE. THEY EXCHANGED 20 INTERMITTENT CATHETERS BECAUSE THERE WAS A PROBLEM WITH THE TAPERING ON THEM. SOME WERE TOO SMALL AND SOME TOO BIG. IT WAS UNCOMFORTABLE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 21460991 ↗
• MalfunctionFeb 25, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT INTERMITTENT CATHETERS WERE INCONSISTENT IN SIZE, AND SOME WERE REALLY BIG AT THE TIP AND SOME VERY SMALL. REPRESENTATIVE ADVISED CUSTOMER WOULD SEND UNUSED TO LIBERATOR REPRESENTATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21457909 ↗
• MalfunctionJan 16, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT CUSTOMER RECEIVED BARD INTERMITTENT CATHETERS, AND THEY WERE ORANGE, AND THEY WERE ROUGH EVEN WITH THE STERILE LUBRICATION JELLY. THEY REMEMBER A WHILE AGO THAT THEY WERE RED AND SOMEWHAT SMOOTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21168245 ↗
• MalfunctionJun 6, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE CUSTOMER USED OF ONE HAND AND COULD GET THETIEMANN CATHETER 2/4 OF THE WAY IN BUT THEN THE TIEMANN CATHETER BENDS.IT WAS STATED THAT THE CAREGIVER COULD GET IT IN WITH NO ISSUE BUT THEY COULD NOT.IT WAS SENT SAMPLES BUT THEY WERE NOT WORKING WELL EITHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475696 ↗
• MalfunctionMar 20, 2024Decrease in Pressure; Material Puncture/Hole; Decrease in Pressure; Material Puncture/Hole

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER DEFLATED ON ITS OWN AND FELL OUT OF THE PATIENT. THE BALLOON WAS INFLATED TO 10CC DURING INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18939628 ↗
• MalfunctionFeb 27, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT STILL MISSING 6 OUT OF THE INTERMITTENT CATHETER FROM THE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18787633 ↗
• MalfunctionSep 6, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT CUSTOMER RECEIVED 10 OF THE INTERMITTENT CATHETER AND NOTED THAT SOME OF THE CATHETER HAD BLACK RESIDUE ON THE TIPS AND SOME DID NOT. PER NOTIFICATION FROM INVESTIGATOR ON (B)(6) 2022, DURING SAMPLE EVALUATION IT WAS FOUND THAT ONE OF THE INTERMITTENT CATHETER WAS FOUND TO HAVE A POORLY CUT FUNNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363312 ↗
• MalfunctionJun 13, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE INTERMITTENT COUDE CATHETER KIT WITH THE BAG ATTACHED WAS USED AND PATIENT HAD OVER 1000 ML IN THE BLADDER AS PER SCAN BUT WHEN CUSTOMER INSERTED THE CATHETER, NOTHING DRAINED. THEY TROUBLESHOOTED FOR A BIT AND FINALLY REMOVED THE CATHETER. UPON EXAMINATION, THE TIP OF THE CATHETER HAS NO FENESTRATIONS OR HOLES TO ALLOW THE URINE TO DRAIN. PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON 07JUN2022, IT WAS REPORTED THAT THE PATIENT CATHETERIZED BUT NO URINE RETURNED EVEN THOUGH VOLUME WAS GREATER THAN 1000 ML . AFTER CATHETER WAS REMOVED AND INSPECTION NOTED THAT THERE WERE NO FENESTRATIONS OR HOLES AT THE TIP OF THE CATHETER FOR URINE TO DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14676187 ↗
• MalfunctionMay 3, 2022Nonstandard Device; Device Contamination with Chemical or Other Material; Nonstandard Device; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT CUSTOMER RECEIVED 10 OF THE INTERMITTENT CATHETER AND NOTED THAT SOME OF THE CATHETER HAD BLACK RESIDUE ON THE TIPS AND SOME DID NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14270520 ↗
• MalfunctionApr 26, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE BALL TIP AND THE WORDING DID NOT LINE UP TOGETHER IN THE TIEMANN CATHETER. CUSTOMER SAID THAT THEY WERE HARD TO GET IN FOUR OF NINETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14207075 ↗
• MalfunctionApr 26, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE BALL TIP AND THE WORDING DID NOT LINE UP TOGETHER IN THE TIEMANN CATHETER. CUSTOMER SAID THAT THEY WERE HARD TO GET IN FOUR OF NINETY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14206582 ↗
• MalfunctionMar 13, 2022Nonstandard Device; Device Contamination with Chemical or Other Material; Nonstandard Device; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE TIEMANN CATHETER HAD A FUNK OR UNIDENTIFIABLE SUBSTANCE INSIDE OF IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13753596 ↗
• MalfunctionFeb 24, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT FEW OF INTERMITTENT CATHETERS WAS FOUND DISCOLORED INSIDE THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596169 ↗
• MalfunctionDec 5, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE TIEMANN CATHETER DID NOT HAVE A DRAINAGE HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931159 ↗
• MalfunctionOct 13, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT SOME OF THE TIEMANN CATHETERS WERE DEFECTIVE BECAUSE THEY WERE DIFFICULT TO INSERT, DIFFICULT TO REMOVE AND CAUSED BLEEDING TO THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12627153 ↗
• MalfunctionJul 13, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT INTERMITTENT CATHETERS HAD UNUSUAL BUMP ON IT AND CAUSED PAIN WHEN REMOVING IT FROM PATIENT BODY. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 12160984 ↗
• MalfunctionFeb 2, 2021Device Contaminated During Manufacture or Shipping; Microbial Contamination of Device; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE NURSE FOUND A MOLD IN THE DRAIN HOLE WHEN THE COUDE CATHETER WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11269278 ↗
• MalfunctionAug 29, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD SOMETIMES AND THE COUDE INTERMITTENT CATHETERS ARE KINKED IN THE PACKAGING. THE PATIENT WAS UPSET TO DISCOVER RED RUBBER COUDE INTERMITTENT CATHETERS BY BARD ARE MANUFACTURED 2016 AND EARLIER. ALSO WHEN THE PATIENT USED THE HYDROPHILIC, IT WOULD NOT ABSORB THE WATER. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10469627 ↗
• MalfunctionJun 19, 2020Material Twisted/Bent

  IT WAS REPORTED THAT THE RED RUBBER CATHETERS PURCHASED FROM THREE DIFFERENT VENDORS WERE TWISTED TO THE POINT AND WERE UNUSABLE. IT WAS ALSO REPORTED THAT THE HYDROGEL COATING OF MAGIC3 CATHETERS WERE NOT SLIPPERY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10176583 ↗
• MalfunctionAug 26, 2019Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement

  IT WAS REPORTED THAT THE OVERALL DIAMETER OF THE TIEMANN CATHETER WAS LARGER THAN USUAL. THE PATIENT WAS ABLE TO INSERT THE CATHETER AND VOID. THE PATIENT ALLEGEDLY EXPERIENCED BLEEDING; THERE WAS NO MEDICAL INTERVENTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Consequences Or Impact To Patient

  MAUDE report 8932169 ↗
• MalfunctionJul 31, 2019Misassembled; Difficult to Insert; Misassembled

  IT WAS REPORTED THAT THE GUIDE NOTCH ON THE FUNNEL END OF THE COUDE CATHETER WAS 90 DEGREES FROM THE ACTUAL CURVE OF THE CATHETER. THE PATIENT WAS ABLE TO FULLY INSERT THE CATHETER FOR USE; HOWEVER NOTES THAT IT WAS PAINFUL DURING INSERTION AND REMOVAL OF THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 8846600 ↗
• MalfunctionFeb 22, 2019Device Damaged Prior to Use; Material Integrity Problem; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE EYELETS ON THE TIEMANN CATHETER WERE SHARP. THE PATIENT ALLEGEDLY WAS CUT AND EXPERIENCED PAIN WITH THE USE OF THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Laceration(s); Pain

  MAUDE report 8362091 ↗
• MalfunctionFeb 20, 2019Misassembled; Inadequacy of Device Shape and/or Size; Misassembled

  IT WAS REPORTED THAT THE TIP OF THE TIEMANN CATHETER WAS MORE ROUND THAN USUAL. THE PATIENT EXPERIENCED PAIN WHILE USING THE CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Pain

  MAUDE report 8356663 ↗