NovaGold 5201Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729892045), received between Jun 1, 2018 and Nov 3, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2021Material Separation; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Material Separation; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WIRE GOT STUCK AND BROKE INSIDE OF THE PATIENT DURING AND ERCP . THE WIRE WAS RETRIEVED AND NOTHING REMAINED IN THE PATIENT. PER SALESFORCE EVENT (B)(4), IT WAS REPORTED THAT: NOVAGOLD WAS EXPERIENCING A LOT OF RESISTANCE AT THE TIP OF THE CANNULA AND WHEN THE NURSE PULLED THE WIRE BACK IT HAD STRIPPED THE GOLD TIP OFF INTO THE CANNULA TIP AND AWAY FROM THE WIRE CORE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? TRIED TO PUSH WIRE THROUGH THE TIP OF THE CANNULA AND IT DIDN'T PASS THROUGH WHAT IS THE NEXT COURSE OF ACTION? NOTHING RESOLVED IT, WHEN THEY PULLED THE WIRE OUT IT STRIPPED THE GOLD TIP OFF. FAILURE MODES RELATED TO THIS DEVICE INCLUDE: DEVICE-GUIDEWIRE INTERACTION WERE THE ISSUES PRESENT UPON OPENING THE PACKAGE?: NO INDICATE ANY ATTACHED/RELATED DEVICE(S): NOVAGOLD GUIDEWIRE DEVICE 2 OF 2 EVENT DATE: (B)(6) 2021.

  Patient problems: Foreign Body In Patient

  MAUDE report 12743405 ↗
• MalfunctionJun 1, 2018Fracture; Fracture

  IT WAS REPORTED THAT ERCP WAS PERFORMED FOR REMOVAL OF STONE. SINCE CANNULATION WAS DIFFICULT, CONTOUR 5-4-3 TIP AND NOVA GOLD WERE USED. THE PHYSICIAN ATTEMPTED TO PERFORM CANNULATION AIMING AT THE BILE DUCT. IT COULD ONLY BE INSERTED INTO THE PANCREATIC DUCT, SO IN ORDER TO PERFORM PANCREATIC DUCTAL GW METHOD, THE INSERTED NOVA GOLD WAS PLACED IN THE PANCREATIC DUCT AND WHEN THE PHYSICIAN TRIED TO REMOVE THE CANNULA, THE TIP OF THE NOVA GOLD GOT DETACHED. ACCORDING TO THE ASSISTANT, THERE WAS A FEELING OF RESISTANCE WHEN REMOVING THE CANNULA. THE TIP OF NOVA GOLD REMAINED IN THE PANCREATIC DUCT, SO ACCIDENT REPORT WILL BE REPORTED AT THE FACILITY. DELIBERATE INVESTIGATION HAS BEEN REQUESTED ABOUT THE OCCURRENCE OF THE ISSUE.

  Patient problems: Fever; Foreign Body In Patient

  MAUDE report 7560847 ↗