Bard® Hydro-Glide™ Guidewire 145FS38Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741053269), received between Sep 5, 2023 and Dec 23, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE GUIDEWIRE WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21000087 ↗
• MalfunctionNov 20, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UNIDENTIFIED WHITE POWDERS KEPT FALLING FROM THE GUIDEWIRE WHILE MOVING FORTH AND BACK. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 07NOV2024, CUSTOMER CONFIRMED THAT THERE WAS NO DIRECT IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733598 ↗
• MalfunctionApr 18, 2024Flaked; Flaked

  IT WAS REPORTED THAT HYDROPHILIC FILM COATING CAME OFF IN THE PATIENT. ALMOST LIKE A SNAKESKIN. THEY OPENED ANOTHER WIRE. PER FOLLOW-UP INFORMATION RECEIVED ON 10APR2024, IT WAS REPORTED THAT THERE WERE A TOTAL OF 29 WIRES PULLED OFF THE SHELF AFTER THE INCIDENT WITH THE REPORTED WIRE THAT WAS FLAKING. THAT PARTICULAR WIRE WAS DISCARDED. NO PATIENT HARM WAS REPORTED. CUSTOMER HAS THE REMAINING 29 THAT WILL BE SENT IN FOR SAMPLE. PER SAMPLE RECEIVED ON 30APR2024, THE CUSTOMER RETURNED SIX ADDITIONAL LOT NUMBERS FOR (BATCH#GFHW0335), (BATCH#GFHV2176, (BATCH#GFHX1239), (BATCH# GFHX1243), (BATCH#GFGR2107) AND (BATCH#GFGR2531).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132813 ↗
• InjurySep 5, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY STATED NO, THE GUIDEWIRE WAS NOT SUCCESSFUL IN PROVIDING TRANSURETHRAL OR PERCUTANEOUS ACCESS INTO THE BLADDER, URETER AND RENAL PELVIS BECAUSE COMPLETE OBLITERATION OF URETHRAL LUMEN IN RELATION TO GUIDEWIRE, HYDROGLIDE¿, FLEXIBLE STRAIGHT TIP, FIXED CORE, STANDARD TAPER, HYDROPHILIC, 145CM LONG, .038, STERILE. MEDICAL INTERVENTION WAS UNKNOWN. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 23AUG2023, IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED THAT NO, THE GUIDEWIRE WAS NOT SUCCESSFUL IN PROVIDING TRANSURETHRAL ACCESS INTO THE BLADDER BECAUSE COMPLETE OBLITERATION OF URETHRAL LUMEN IN RELATION TO 145FS38 - GUIDEWIRE, HYDROGLIDE¿, FLEXIBLE STRAIGHT TIP, FIXED CORE, STANDARD TAPER, HYDROPHILIC, 145CM LONG, .038, STERILE.

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

  MAUDE report 17682096 ↗
• InjurySep 5, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  CRITICAL CARE NURSES REPORTED THAT NO, THE GUIDEWIRE WAS NOT SUCCESSFUL IN PROVIDING TRANSURETHRAL/PERCUTANEOUS ACCESS INTO THE BLADDER/URETER/RENAL PELVIS BECAUSE COMPLETE OBLITERATION OF URETHRAL LUMEN IN RELATION TO 145FS38 - GUIDEWIRE HYDROGLIDE FLEXIBLE STRAIGHT TIP FIXED CORE STANDARD TAPER HYDROPHILIC 145CM LONG .038 STERILE. MEDICAL INTERVENTION WAS UNKNOWN.

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

  MAUDE report 17682095 ↗