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NovaGold 5200Recalls & reported problems

Heraeus Medical Components LLC · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729892038), received between Apr 25, 2023 and Apr 25, 2023 — classified as 1 malfunction.

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

Device problems

  • Material Fragmentation1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 25, 2023Material Fragmentation; Material Fragmentation

    PHYSICIAN PERFORMED AN OFF LABEL AXIOS CASE TO CONNECT THE GI TRACT TO THE BILE DUCT. PHYSICIAN USED A NOVAGOLD WIRE (LENGTH UNKNOWN PER THE ACCOUNT) IN AXIOS FOR THE CASE. THE WIRE BROKE AND WAS LEFT IN THE PATIENT. THE WIRE WAS RETRIEVED IN A FOLLOW UP PROCEDURE VIA SPYGLASS AND SPYBITE. NO HARM WAS NOTED TO THE PATIENT.

    Patient problems: Foreign Body In Patient

    MAUDE report 16805966 ↗

Other Endoscopic Guidewire, Gastroenterology-Urology devices

All Endoscopic Guidewire, Gastroenterology-Urology devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.