Bard Delux Guidewire PEG System 000793Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741000478), received between Aug 17, 2017 and Jan 13, 2022 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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.

• MalfunctionJan 13, 2022Fluid/Blood Leak; Fitting Problem; Fluid/Blood Leak; Fitting Problem

  IT WAS REPORTED THAT DURING A FEEDING TUBE PLACEMENT PROCEDURE, THE FEEDING CONNECTOR WAS ALLEGEDLY FOUND TO BE LOOSE AND FLUID LEAKS OUT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13251589 ↗
• InjuryApr 29, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE GUIDEWIRE IN THE PEG SYSTEM ALLEGEDLY BROKE AND PUNCTURED THE HEALTHCARE PROVIDER'S FINGERS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 11743263 ↗
• MalfunctionMar 10, 2021Fracture; Difficult to Remove; Fracture; Difficult to Remove

  IT WAS REPORTED THAT DURING FEEDING DEVICE PLACEMENT PROCEDURE, THE DEVICE GUIDEWIRE ALLEGEDLY FRAYED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS ALLEGEDLY DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11449800 ↗
• MalfunctionMar 5, 2021Break; Fracture; Material Separation; Stretched; Deformation Due to Compressive Stress; Break; Fracture; Material Separation; Stretched; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING FEEDING DEVICE PLACEMENT PROCEDURE, THE DEVICE GUIDE WIRE ALLEGEDLY FRAYED. IT WAS FURTHER REPORTED THAT GUIDE WIRE ALLEGEDLY BROKEN INSIDE PATIENT AND REMOVED THE SEGMENTS USING SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419855 ↗
• MalfunctionJul 3, 2020Fracture; Fracture

  IT WAS REPORTED DURING INSERTION OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY, THE TIP OF THE DEVICE WAS ALLEGEDLY SPLIT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10228960 ↗
• MalfunctionApr 19, 2019Component Missing; Component Missing

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL 793 20F GUIDEWIRE DELUXE PEG EXPERIENCED A MISSING COMPONENT. OF THIS EVENT, THE DEVICE WAS NOT USED ON THE PATIENT. THE AGE, SEX, AND WEIGHT OF THE PATIENT WAS NOT PROVIDED. THE 793 20F GUIDEWIRE WAS NOT RETURNED TO THE MANUFACTURER LIMITING INVESTIGATION. A DHR REVIEW WAS PERFORMED ON THE GIVEN LOT NUMBER AND FOUND NO NONCONFORMANCE ISSUES.

  Patient problems: No Patient Involvement

  MAUDE report 8533221 ↗
• MalfunctionOct 9, 2018Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE GUIDEWIRE IN THE PEG KIT WAS FRAYED. THE DEVICE WAS NOT USED ON THE PATIENT. A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 7950147 ↗
• MalfunctionOct 8, 2018Material Frayed; Material Frayed

  IT WAS REPORTED BY THE FACILITY THAT THE INSERTION WIRE WOULD NOT FEED THROUGH THE PEG TUBE. A SECOND DEVICE WAS OPENED AND THE PHYSICIAN WAS UNABLE TO OPEN THE SNARE. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THIS FILE ADDRESSES THE ALLEGEDLY DEFECTIVE INSERTION WIRE. NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7943784 ↗
• MalfunctionMay 3, 2018Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE GUIDEWIRE GOT STUCK IN THE "BLUE HOLDER" AND WHEN PULLED, IT STRETCHED, CAUSING THE FRONT END TO BECOME VERY THIN AND FLOPPY. A SECOND KIT WAS OPENED TO FINISH THE PROCEDURE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7485228 ↗
• MalfunctionMar 26, 2018Bent; Out-Of-Box Failure

  IT WAS REPORTED THAT THE DEVICE WAS NOT USED ON THE PATIENT. AS THE DEVICE WAS REMOVED FROM THE PACKAGING IT WAS NOTED TO BE BENT. ANOTHER GUIDEWIRE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY. NO PATIENT INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7370259 ↗
• MalfunctionAug 31, 2017Material Frayed

  FACILITY REPORTED TO M&S THAT DURING PLACEMENT THE GUIDEWIRE FRAYED AND A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6835167 ↗
• MalfunctionAug 31, 2017Material Frayed

  FACILITY REPORTED TO MEDICAL SERVICES THAT DURING PLACEMENT THE GUIDEWIRE FRAYED. THIS HAS OCCURRED THREE TIMES. THE INITIAL OCCURRENCE WAS APPROXIMATELY SIX MONTHS AGO. THE COMPLAINANT DID NOT REPORT THE INITIAL OCCURRENCE AND DOES NOT HAVE ANY PRODUCT INFORMATION. NURSE STATED THAT THE SAME THING OCCURRED YESTERDAY. DURING PLACEMENT THE GUIDEWIRE FRAYED AND A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6835159 ↗
• MalfunctionAug 17, 2017Device Contamination with Chemical or Other Material; Material Integrity Problem

  PER MS&S, CUSTOMER NEEDS TO CONFIRM IF WE RECENTLY MADE CHANGES TO THE PEG GUIDEWIRE KIT. SHE DESCRIBED THE "JUNCTION HAVING FILM OR TAPE AROUND IT." SHE DESCRIBED THE "JUNCTION" AS THE " PART WHERE ITS PULLED THROUGH THE STOMACH." SHE STATED THE TAPE OR FILM "ALMOST CAUSED THE PHYSICIAN TO SWITCH TO AN OPEN PROCEDURE". MS&S FORWARDED THE CASE TO BAS (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6802431 ↗