AMPLATZ GOOSE NECK GN3500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684004050), received between Feb 19, 2021 and Feb 19, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K972511); they may or may not involve this specific model.

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

• MalfunctionFeb 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT IS REPORTED THAT A GOOSENECK SNARE DEVICE WAS USED DURING A PATIENT PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT IS REPORTED DEVICE OR DEVICE FRAGMENTS REMAIN IN THE PATIENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347336 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972511. One submission often covers many models, so check the product and lot details in each record.

• Z-0992-2007 · May 18, 2007 · Terminated
  Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA THE ENDOVASCULAR COMPANY. The