Bard Hydro-Glide GuidewireRecalls & reported problems across all models
C. R. Bard, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 3 models of Bard Hydro-Glide Guidewire by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Jul 10, 2019 and Dec 23, 2024 — classified as 4 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Flaked” (23 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 Bard Hydro-Glide Guidewire problems
Device problems
- Flaked23
- Difficult to Insert3
- Device Contamination with Chemical or Other Material2
- Material Fragmentation2
- Patient Device Interaction Problem2
- Accessory Incompatible1
- Inadequacy of Device Shape and/or Size1
- Incorrect Measurement1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Exposure to Body Fluids1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Bard Hydro-Glide Guidewire models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® Hydro-Glide™ Guidewire 145FS35STYLET FOR CATHETER, GASTRO-UROLOGY31 reports
- Bard® Hydro-Glide™ Guidewire 145FS38STYLET FOR CATHETER, GASTRO-UROLOGY5 reports
- Bard® Hydro-Glide™ Guidewire 145FS25STYLET FOR CATHETER, GASTRO-UROLOGY1 report
Recent Bard Hydro-Glide Guidewire adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJun 21, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE GUIDEWIRE OF PROXIMAL TIP WAS DAMAGED WHEN LOOKING AT THE PROXIMAL TIP BEFORE USING IT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2024, THEY CONFIRMED THE PROXIMAL TIP SEEMED TO BE A LITTLE BIT BROKEN WHEN CHECKING FOR THE PRODUCT BEFORE USING IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583419 ↗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 ↗MalfunctionSep 15, 2023Difficult to Insert; Difficult to Insert
CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE GUIDEWIRE WAS NOT SUCCESSFUL IN PROVIDING TRANSURETHRAL ACCESS INTO THE URETER BECAUSE URETERAL CALCULUS WAS NOT ALLOWING PASSAGE OF THE GUIDEWIRE IN RELATION TO 145FS35: GUIDEWIRE, HYDROGLIDETM, FLEXIBLE STRAIGHT TIP, FIXED CORE, STANDARD TAPER, HYDROPHILIC, 145CM LONG,.035", STERILE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17754601 ↗MalfunctionSep 15, 2023Difficult to Insert; Difficult to Insert
CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE GUIDEWIRE WAS NOT SUCCESSFUL IN PROVIDING PERCUTANEOUS ACCESS INTO THE RENAL PELVIS DUE TO STONE OBSTRUCTION IN THE RENAL INFUNDIBULUM, WHICH DID NOT ALLOW ACCESS TO THE GUIDEWIRE IN RELATION TO 145FS35: GUIDEWIRE, HYDROGLIDETM, FLEXIBLE STRAIGHT TIP, FIXED CORE, STANDARD TAPER, HYDROPHILIC, 145CM LONG,.035", STERILE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17754598 ↗MalfunctionSep 12, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT PURPLE COATING COLOR OF THE GUIDEWIRE WAS PEELING AND COULD BE SEEN UNDER ENDOSCOPY. STATED THAT THE USER WAS EXPOSED TO HAZARDOUS, BLOOD, OR BODILY FLUIDS. THE USER NEEDED TO REINSERT A NEW GUIDEWIRE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. PER SAMPLE EVALUATION NOTIFICATION RECEIVED ON 22AUG2023, STATED THAT THE GUIDEWIRE WAS FOUND TO BE EXPOSED DURING THE SAMPLE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17729261 ↗InjurySep 11, 2023Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT IN THE ONLINE SURVEY A PHYSICIAN STATED THAT NO, THE GUIDEWIRE WAS NOT SUCCESSFUL IN PROVIDING TRANSURETHRAL/PERCUTANEOUS ACCESS INTO THE BLADDER/URETER/RENAL PELVIS BECAUSE IMPACTED STONE AT THE PROXIMAL URETER, ATTEMPTED MULTIPLE WIRES. THEY REQUIRED A PERCUTANEOUS NEPHROSTOMY FOR AN INFECTED STONE IN RELATION TO 145FS35 - GUIDEWIRE, HYDROGLIDE¿, FLEXIBLE STRAIGHT TIP, FIXED CORE, STANDARD TAPER, HYDROPHILIC, 145CM LONG, .035 INCH, STERILE. 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 RENAL PELVIS BECAUSE IMPACTED STONE AT THE PROXIMAL URETER, ATTEMPTED MULTIPLE WIRES. THEY REQUIRED A PERCUTANEOUS NEPHROSTOMY FOR AN INFECTED STONE IN RELATION TO 145FS35 - GUIDEWIRE, HYDROGLIDE¿, FLEXIBLE STRAIGHT TIP, FIXED CORE, STANDARD TAPER, HYDROPHILIC, 145CM LONG, .035", STERILE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17718589 ↗MalfunctionSep 6, 2023Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT A PHYSICIAN IN AN ONLINE SURVEY STATED THAT "NO, THE GUIDEWIRE WAS NOT SUCCESSFUL IN PROVIDING TRANSURETHRAL ACCESS INTO THE URETER¿ BECAUSE "HAD TO DO THE PROCEDURE AGAIN" IN RELATION TO THE HYDROGLIDE GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17689452 ↗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 ↗MalfunctionAug 14, 2023Flaked; Flaked
IT WAS REPORTED THAT THE MATERIAL FELL OFF FROM SHEATH SURFACE OF THE HYDRO-GLIDE GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17540222 ↗MalfunctionJul 28, 2023Flaked; Flaked
IT WAS REPORTED THAT DURING USE OF THE URETHRAL STENT ON (B)(6) 2023, THE GUIDE WIRE WAS FOUND UNSMOOTH WITH THE COATING FLAKING OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17413709 ↗MalfunctionJul 11, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT GUIDEWIRE HAD WHITE DROPS THAT LOOK LIKE MAGGOTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17298308 ↗InjuryMay 12, 2023Flaked; Flaked
IT WAS REPORTED THAT PURPLE COATING COLOR OF THE GUIDEWIRE WAS PEELING AND COULD BE SEEN UNDER ENDOSCOPY. STATED THAT THE USER WAS EXPOSED TO HAZARDOUS, BLOOD, OR BODILY FLUIDS. THE USER NEEDED TO REINSERT A NEW GUIDEWIRE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED. PER SAMPLE EVALUATION NOTIFICATION RECEIVED ON 22AUG2023, STATED THAT THE GUIDEWIRE WAS FOUND TO BE EXPOSED DURING THE SAMPLE EVALUATION.
Patient problems: Exposure to Body Fluids
MAUDE report 16918309 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
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- 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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