Bard PEG Safety System 003030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741081170), received between Mar 17, 2020 and Sep 29, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2020Fracture; Fracture

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE GUIDEWIRE WAS ALLEGEDLY FOUND TO BE LIMP AND NOT STIFF. IT WAS FURTHER REPORTED THAT THE INNER WIRE WAS FOUND TO BE CRACKED AND POKING THROUGH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 10599353 ↗
• MalfunctionApr 1, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING GASTROSTOMY FEEDING TUBE PLACEMENT, THE GUIDEWIRE WAS ALLEGEDLY UNWOUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914304 ↗
• MalfunctionApr 1, 2020Fracture; Material Frayed; Fracture; Material Frayed

  IT WAS REPORTED THAT DURING GASTROSTOMY FEEDING TUBE PLACEMENT, THE GUIDEWIRE WAS ALLEGEDLY UNWOUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914302 ↗
• MalfunctionMar 17, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE LIDOCAINE COMPONENT WAS ALLEGEDLY MISSING FROM THE KIT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9845057 ↗