AMPLATZ GOOSE NECK™ SK700Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000225414), received between Jul 30, 2021 and Jul 30, 2021 — classified as 1 malfunction.

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

• MalfunctionJul 30, 2021Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING USE TO THE MICROSNARE DURING PROCEDURE TO TREAT LITTLE CALCIFIED PLAQUE IN THE DISTAL COMMON ILIAC ARTERY WITH CHRONIC TOTAL OCCLUSION (100%).THE VESSEL WAS MODERATELY TORTUOUS WITH DIAMETER 8MM AND LENGTH 40MM. A NON-MEDTRONIC (TERUMO STIFF ANGLED GLIDEWIRE) GUIDEWIRE WAS USED IN THE PROCEDURE. THE DEVICE WAS INSPECTED AND PREPPED AS PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE SNARE HOOP BROKE IN HALF WHILE TRYING TO CAPTURE THE WIRE. THE BROKEN SNARE AND WIRE WERE REMOVED FROM THE PATIENT THROUGH THE SHEATH. THERE WAS STILL A THREAD OF WIRE IN THE SHEATH AND THAT WAS REMOVED WHEN THE SHEATH WAS PULLED MANUALLY AND PRESSURE HELD IN POST OP. THERE WAS NO VESSEL DAMAGE NOTED. NO INTERVENTION REQUIRED FOR THE REMOVAL OF THE SNARE FROM THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12251144 ↗