Bard® Tiemann Model Urological Catheter Coude Tip 010112Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741029851), received between Nov 14, 2017 and Jul 18, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Bent” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2026Material Protrusion/Extrusion

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 25867180 ↗
• InjuryJul 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE USER USED EXPIRED COUDE CATHETER AND SHORTLY AFTER THE USE GOT A URINARY TRACT INFECTION. COUDE CATHETER WAS EXPIRED IN 2022 AND WAS USED BY (B)(6)2025. REPRESENTATIVE INFORMED PATIENT THAT THEY DID NOT HAVE AN EXPIRATION EXTENSION LETTER AND THEY DID NOT RECOMMEND THE USE OF EXPIRED PRODUCTS.. THEY SUGGESTED TO REACH OUT TO HEALTH CARE PROFESSIONAL AS BD COULDN'T IDENTIFY THE CAUSE OF UTI.

  Patient problems: Sepsis; Unspecified Infection; Urinary Tract Infection

  MAUDE report 22589515 ↗
• MalfunctionJul 23, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE PATIENT ARRIVED FOR BACILLE CALMETTE-GUÉRIN TREATMENT AND WAS PREPPED AND USED A BARD #12 FRENCH UROLOGICAL CATHETER TIEMANN MODEL, COUDE TIP INSERTED BLADDER WAS DRAINED, BCG PLACED TO THE HUB OF THE CATHETER AND BEGAN TO INFUSE. A PIN HOLE NOTED AT THE HUB OF THE CATHETER. IMMEDIATELY STOPPED TREATMENT. SECOND CATHETER OPENED, NOTED PIN HOLE, NOT USED. OPENED BARD #14 COUDE TIP, NO PIN HOLE NOTED. UNDER STERILE TECHNIQUE, A CATHETER INSERTED AND TREATMENT GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576225 ↗
• MalfunctionJun 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PATIENT ARRIVED FOR THEIR BCG TREATMENT WAS PREPPED AND USED BARD #12 FRENCH UROLOGICAL CATHETER TIEMANN MODEL COUDE TIP WAS INSERTED INTO BLADDER WAS DRAINED, BCG PLACE THE HUB OF THE CATHETER AND BEGAN TO INFUSE, PIN HOLE NOTED AT THE HUB OF THE INTERMITTENT CATHETER. IMMEDIATELY STOPPED TREATMENT. SECOND CATHETER OPENED NOTED PIN HOLE, NOT USED. OPENED BARD #14 COUDE TIP NO PIN HOLE NOTED. UNDER STERILE TECHNIQUE CATHETER INSERTED AND TREATMENT GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293187 ↗
• MalfunctionJun 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT PATIENT ARRIVED FOR THEIR BCG TREATMENT WAS PREPPED AND USED BARD #12 FRENCH UROLOGICAL CATHETER TIEMANN MODEL COUDE TIP WAS INSERTED INTO BLADDER WAS DRAINED, BCG PLACE THE HUB OF THE CATHETER AND BEGAN TO INFUSE, PIN HOLE NOTED AT THE HUB OF THE INTERMITTENT CATHETER. IMMEDIATELY STOPPED TREATMENT. SECOND CATHETER OPENED NOTED PIN HOLE, NOT USED. OPENED BARD #14 COUDE TIP NO PIN HOLE NOTED. UNDER STERILE TECHNIQUE CATHETER INSERTED AND TREATMENT GIVEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293034 ↗
• MalfunctionNov 16, 2017Bent; Difficult to Insert

  IT WAS REPORTED THAT THE COUDE TIP WAS BENT MORE THAN USUAL; THEREFORE, THE PATIENT COULD NOT INSERT THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038647 ↗
• MalfunctionNov 16, 2017Bent; Failure to Advance

  IT WAS REPORTED THAT THE COUDE TIP WAS BENT MORE THAN USUAL; THEREFORE, THE PATIENT COULD NOT INSERT THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038339 ↗
• MalfunctionNov 16, 2017Bent; Difficult to Insert

  IT WAS REPORTED THAT THE COUDE TIP WAS BENT MORE THAN USUAL; THEREFORE, THE PATIENT COULD NOT INSERT THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038234 ↗
• MalfunctionNov 16, 2017Break; Difficult to Insert

  IT WAS REPORTED THAT THE COUDE TIP WAS BENT MORE THAN USUAL; THEREFORE, THE PATIENT COULD NOT INSERT THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038216 ↗
• MalfunctionNov 16, 2017Material Deformation

  IT WAS REPORTED THAT THE COUDE TIP WAS BENT MORE THAN USUAL, THEREFORE, THE PATIENT COULD NOT INSERT THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036767 ↗
• MalfunctionNov 16, 2017Bent; Difficult to Insert

  IT WAS REPORTED THAT THE COUDE TIP WAS BENT MORE THAN USUAL; THEREFORE, THE PATIENT COULD NOT INSERT THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036626 ↗
• MalfunctionNov 16, 2017Bent

  IT WAS REPORTED THAT THE COUDE TIP WAS BENT MORE THAN USUAL; THEREFORE, THE PATIENT COULD NOT INSERT THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036446 ↗
• MalfunctionNov 14, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER WAS CURLED MAKING IT DIFFICULT TO INSERT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7028470 ↗