AMPLATZ GOOSE NECK™ GN1500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000225261), received between Apr 13, 2022 and Jul 16, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ATTEMPTED TO USE A GOOSENECK SNARE WITH A NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A CALCIFIED LESION IN THE PATIENTS LEFT DISTAL TIBIAL/POPLITEAL TRUNK. MODERATE VESSEL CALCIFICATION WAS REPORTED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS USED. THE VESSEL WAS PRE AND POST DILATED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE RADIOPAQUE MARKER ON THE SNARE CATHETER DISLODGED AND WAS JAILED WITH A CORONARY STENT. A SECOND SNARE WAS OPENED AND THE INTERGRAGED EMBOLIC PROTECTION WAS REMOVED BUT THE RADIOPAQUE SNARE MARKER WAS LEFT IN THE PATIENT. NO HEALTH CONSEQUENCES OR IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750159 ↗
• MalfunctionOct 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A GOOSENECK SNARE WAS USED FOR GASTRIC SURGERY. IT WAS REPORTED THAT THE RADIOPAQUE MARKER OF SNARE SHEATH WAS SEPARATED FROM THE SHEATH AND DROPPED IN THE DISTAL ARTERY OF GASTRIC. THE RADIOPAQUE MARKER WHICH IS DETACHED FROM SNARE SHEATH REMAINS IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697196 ↗
• MalfunctionApr 13, 2022Material Deformation; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE THE MICRO SNARE DEVICE DURING PROCEDURE. THE DEVICE WAS INSPECTED AND PREPPED PER IFU WITH NO ISSUES. IT WAS REPORTED THAT THERE WAS A BREAK AND THE SNARE CATHETER HAD CUT. IT IS UNKNOWN IF DETACHMENT OCCURRED. IT IS UNKNOWN IF THE WIRE WAS FRAYED OR STRIPED. THE CUT IN SNARE OCCURRED IN VIVO. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14099297 ↗

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