AMPLATZ GOOSE NECK GN1500Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00821684004036), received between Jan 24, 2019 and Oct 2, 2024 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A GOOSENECK SNARE TO TREAT A LESION. IFU WAS FOLLOWED HOWEVER, CATHETER DISCONNECTED (CUT OFF). A NEW PACKAGE WAS OPENED TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351458 ↗
• MalfunctionAug 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN WAS ATTEMPTING TO USE A GOOSENECK SNARE DURING AN UNKNOWN PROCEDURE. THE DEVICE WAS DEVICE INSPECTED WITH NO ISSUES IDENTIFIED. THE IFU WAS FOLLOWED AND NO ISSUES WERE IDENTIFIED. IT WAS REPORTED DURING THE PROCEDURE THAT A BREAK OCCURRED. NO PATIENT INJURY WAS REPORTED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15314234 ↗
• MalfunctionAug 11, 2021Fracture; Fracture

  PHYSICIAN ATTEMPTED TO USE A GOOSENECK SNARE DURING A PROCEDURE. IT IS REPORTED THE SNARE CATHETER FRACTURED. THE FRACTURE DID NOT OCCUR DURING PREP. THE DEVICE DID NOT FRACTURE WITHIN THE PATIENT. ALL COMPONENTS OF THE DEVICE WERE REMOVED FROM THE PATIENT. THE SNARE WAS SAFELY REMOVED FROM THE PATIENT. NO ADDITIONAL INTERVENTION WAS REQUIRED FOR THE REMOVAL OF THE DEVICE FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THE PROCEDURE WAS COMPLETED WITH A NEW MEDTRONIC DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306559 ↗
• InjuryAug 3, 2021Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; Detachment of Device or Device Component

  PHYSICIAN WAS ATTEMPTING TO USE THE SNARE RETRIEVAL DEVICE DURING PROCEDURE FOR NON-MEDTRONIC AORTIC VALVE REPLACEMENT. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED AND WAS PREPARED AS PER IFU. IT WAS REPORTED THAT KINK DAMAGE OCCURRED DURING INSERTION INTO THEPATIENT. THE LOOP FROM THE SNARE DETACHED IN THE PATIENT. THE CATCHING RING FELL OFF AND ANOTHER SNARE WAS USED FOR RETRIEVAL. THE LOOP FROM THE DETACHED SNARE WAS ATTEMPTED TO BE RETRIEVED WITH THE SECOND SNARE HOWEVER, THE SECOND SNARE FAILED TO RETRIEVE THE DETACHED LOOP. THE DETACHED COMPONENT WAS LEFT IN PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12264670 ↗
• MalfunctionJan 7, 2020Fracture; Device Damaged by Another Device; Fracture; Device Damaged by Another Device

  PHYSICIAN USED A GOOSENECK SNARE DURING TREATMENT OF THE PATIENT¿S MID LEFT PULMONARY ARTERY. MODERATE VESSEL TORTUOSITY IS REPORTED. IFU WAS FOLLOWED AND THE DEVICE WAS PREPPED WITHOUT ISSUE. IT IS REPORTED THAT FOLLOWING REMOVAL OF THE TEMPORARY FILTER THE GOOSENECK SNARE WAS USED. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE GOOSENECK SNARE, THE LOOP BECAME CONNECTED TO THE CATHETER AND THE MARKER PORTION BECAME FRACTURED. THE FRACTURED PORTION REMAINS IN THE PATIENT. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9557189 ↗
• MalfunctionAug 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE AMPLATZ GOOSE NECK SNARE WAS PREPARED AS PER IFU. THE CATHETER WAS USED AS INTENDED HOWEVER, THE DEVICE BECAME DAMAGED DURING THE PROCEDURE. ANOTHER SNARE OF THE SAME SPECIFICATION WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8933792 ↗
• InjuryFeb 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE AN AMPLATZ GOOSE NECK SNARE KIT. IT WAS REPORTED THAT THE METALLIC MARKER AT THE TIP OF THE CATHETER DISLODGED DURING NORMAL USE, EMBOLISED AND LODGED IN A VERY SMALL BRANCH OF THE R LUNG. THE PIECE WAS VERY SMALL AND WAS DIFFICULT TO RETRIEVE AND THEREFORE WAS LEFT IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8319685 ↗
• InjuryJan 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN USED A GOOSENECK SNARE IN THE DISTAL RIGHT PULMONARY ARTERY. THE DEVICE WAS INSPECTED BEFORE USE AND NO ISSUES WERE IDENTIFIED. POST PROCEDURE IT WAS NOTICED THAT THE RADIO OPAQUE MARKER HAD COMPLETELY SEPARATED FROM THE END OF THE CATHETER. IT WAS REPORTED THAT THE DEVICE FRAGMENT REMAINS IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8273409 ↗

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