AMPLATZ GOOSE NECK GN1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684004029), received between Oct 26, 2021 and Oct 26, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryOct 26, 2021Difficult to Remove; Difficult to Remove

  PHYSICIAN WAS ATTEMPTING TO USE NANOCROSS PTA BALLOON CATHETER ALONG WITH 6FR SHEATH, 0.014" AND SPIDER 5.0 EMBOLIC PROTECTION DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED LESION IN THE RIGHT PROXIMAL COMMON ILIAC ARTERY AND SUPERFICIAL FEMORAL ARTERY (SFA) WITH 70-80% STENOSIS. EVEREST INFLATION DEVICE WAS USED TO INFLATE BALLOON. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THERE WAS BALLOON DEFLATION DIFFICULTIES REPORTED, THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. THE VESSEL WAS PRE DILATED BUT NOT POST DILATED. THE SPIDER WAS UNABLE TO CROSS. IT WAS REPORTED THAT DURING ATTEMPT TO REMOVE FROM THE VESSEL, THE BALLOON DETACHED. DAMAGE WAS NOTED TO THE BALLOON CATHETER. THERE WAS NO ISSUE NOTED DURING INFLATION. THE DETACHED BALLOON WAS REMOVED VIA OPEN SURGERY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. PHYSICIAN WENT IN WITH A 4.0X150 NANOCROSS, DID PTA ON PROXIMAL AND DISTAL SFA. AFTER THE 2ND INFLATION, THE BALLOON DID NOT FULLY DEFLATE. PHYSICIAN TRIED TO REMOVE THE BALLOON, BUT I

  Patient problems: Insufficient Information

  MAUDE report 12696213 ↗

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