Bard® Hydro-Glide™ Guidewire 145FS35Recalls & reported problems
C. R. Bard, Inc. · Bard® Hydro-Glide™ Guidewire · Class 1
All models of Bard Hydro-Glide Guidewire (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Hydro-Glide guidewire is a flexible, hydrophilic-coated wire used to reach the bladder, ureter and kidney during urology procedures. The 31 reports mostly describe the coating flaking or peeling off the wire, sometimes with material breaking off or the tip appearing damaged, plus difficulty passing the wire past stones. Two reports describe injuries. No recalls name this device, and no reports came in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00801741053252), received between Jul 10, 2019 and Jun 21, 2024 — classified as 2 injuries, 29 malfunctions.
The most frequently reported specific device problem is “Flaked” (22 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.
Reports received per month
Most reported problems
Device problems
- Flaked22
- Difficult to Insert2
- Accessory Incompatible1
- Device Contamination with Chemical or Other Material1
- Inadequacy of Device Shape and/or Size1
- Incorrect Measurement1
- Material Fragmentation1
- Material Protrusion/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Exposure to Body Fluids1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 ↗MalfunctionMay 4, 2023Flaked; Flaked
IT WAS REPORTED THAT, GUIDEWIRE PURPLE COATING COLOR PEELING CAN BE SEEN UNDER ENDOSCOPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16869255 ↗MalfunctionMay 4, 2023Flaked; Flaked
IT WAS REPORTED THAT, GUIDEWIRE PURPLE COATING COLOR PEELING COULD BE SEEN UNDER ENDOSCOPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16869249 ↗MalfunctionMay 4, 2023Flaked; Flaked
IT WAS REPORTED THAT PURPLE COATING COLOR OF THE GUIDEWIRE WAS PEELING AND COULD BE SEEN UNDER ENDOSCOPY. AMONG THEM, 3 SAMPLES WOULD BE RETURNED AND ONE WOULD BE HAVING NO SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16867389 ↗MalfunctionMay 2, 2023Flaked; Flaked
IT WAS REPORTED THAT, GUIDEWIRE PURPLE COATING COLOR PEELING CAN BE SEEN UNDER ENDOSCOPY. IT WAS STATED THAT 7 DEVICES WERE REPORTED ISSUE. AMONG THEM, 5 SAMPLES WERE RETURNED AND 2 ARE NO SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16854619 ↗MalfunctionMay 2, 2023Flaked; Flaked
IT WAS REPORTED THAT, GUIDEWIRE PURPLE COATING COLOR PEELING CAN BE SEEN UNDER ENDOSCOPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16852631 ↗MalfunctionMay 2, 2023Flaked; Flaked
IT WAS REPORTED THAT, GUIDEWIRE PURPLE COATING COLOR PEELING CAN BE SEEN UNDER ENDOSCOPY. IT WAS STATED THAT 7 DEVICES WERE REPORTED ISSUE. AMONG THEM, 5 SAMPLES WERE RETURNED AND 2 ARE NO SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16852629 ↗MalfunctionMay 2, 2023Flaked; Flaked
IT WAS REPORTED THAT, GUIDEWIRE PURPLE COATING COLOR PEELING CAN BE SEEN UNDER ENDOSCOPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16852627 ↗MalfunctionMay 1, 2023Flaked; Flaked
IT WAS REPORTED THAT, GUIDEWIRE PURPLE COATING COLOR PEELING CAN BE SEEN UNDER ENDOSCOPY (LOT# GFGR1887 ; LOT# GFGS1239 ).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16844482 ↗MalfunctionMay 1, 2023Flaked; Flaked
IT WAS REPORTED THAT PURPLE COATING COLOR OF THE GUIDEWIRE WAS PEELING AND COULD BE SEEN UNDER ENDOSCOPY. AMONG THEM, (B)(4) SAMPLES WOULD BE RETURNED AND ONE WOULD BE HAVING NO SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16843764 ↗MalfunctionMay 1, 2023Flaked; Flaked
IT WAS REPORTED THAT, GUIDEWIRE PURPLE COATING COLOR PEELING CAN BE SEEN UNDER ENDOSCOPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16843278 ↗MalfunctionApr 28, 2023Flaked; Flaked
IT WAS REPORTED THAT THE HYDRO GLIDE GUIDEWIRE OUTSIDE WAS SHEDDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16832500 ↗MalfunctionApr 28, 2023Flaked; Flaked
IT WAS REPORTED THAT GUIDEWIRE OUT SIDE SHEDDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16832497 ↗MalfunctionApr 6, 2023Flaked; Flaked
IT WAS REPORTED THAT COATING OF THE GUIDEWIRE WAS PEELING. THE DEVICE WAS NOT USED ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16691267 ↗MalfunctionMar 12, 2023Accessory Incompatible; Accessory Incompatible
IT WAS REPORTED THAT THE USER FELT STUCK WHEN USE THE PUSHER OF GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16527260 ↗MalfunctionDec 5, 2022Flaked; Flaked
IT WAS REPORTED THAT GUIDEWIRE PURPLE COATING COLOR PEELING WAS OBSERVED. THE PRODUCT WAS NOT USED ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15915717 ↗MalfunctionNov 30, 2022Flaked; Flaked
IT WAS REPORTED THAT GUIDEWIRE COATING SEEMED TO BE SCRATCHED OFF WHEN GOING THROUGH THE URETEROSCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15886826 ↗
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- Sensor M0066703120Boston Scientific Corporation · STYLET FOR CATHETER, GASTRO-UROLOGY17 reports
- NiCore Nitinol Guidewire 150NSA35C. R. Bard, Inc. · STYLET FOR CATHETER, GASTRO-UROLOGY16 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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