Bard Guidewire PEG System 010061Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741081217), received between Aug 4, 2017 and Apr 19, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2019Material Frayed; Appropriate Device Problem Term/Code Not Available; Material Frayed; Appropriate Device Problem Term/Code Not Available

  THIS REPORT SUMMARIZES ONE MALFUNCTION EVENT. A REVIEW OF THIS EVENT INDICATED THAT MODEL 10061 FEEDING DEVICE EXPERIENCED FRAYED MATERIAL. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THERE WAS NO PATIENT INVOLVEMENT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8531946 ↗
• MalfunctionOct 10, 2018Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THERE WAS DIFFICULTY UNCOILING THE GUIDE WIRE FROM THE PROTECTIVE SHEATH; HOWEVER, THE HEALTH CARE PROVIDER PROCEEDED TO THREAD THE WIRE, FINDING IT HAD KINKED AND WAS UNABLE TO THREAD IT. IT WAS FURTHER REPORTED THAT A SECOND GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7954404 ↗
• MalfunctionAug 4, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT NURSE STATES HER PATIENT HAS A PEG AND THE CAP ALLEGEDLY KEEPS POPPING OPEN AND STOMACH FLUIDS ARE LEAKING. THE DUEL PORT ADAPTER WAS REPLACED, BUT THE ISSUE ALLEGEDLY PERSISTS. PATIENT IS USING TAPE TO KEEP THE CAP IN PLACE. TAPE IS REMOVED WHEN THEY NEED TO ACCESS TO FLUSH. CURRENTLY THE DEVICE IS ONLY BEING OPENED TO FLUSH AND THEN IS BEING TAPED DOWN TO STAY IN PLACE. THE PATIENT IS NOT USING THE G-TUBE AS A FEEDING DEVICE. PATIENT IS CURRENTLY STABLE AND ABLE TO EAT ORALLY, BUT ANTICIPATES THE PATIENTS CONDITION WILL PROGRESS REQUIRING THE G-TUBE TO BE USED FOR NUTRITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6769403 ↗