AMPLATZ GOOSE NECK GN2500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00821684004043), received between Jan 13, 2017 and May 27, 2020 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2020Defective Device; Material Deformation; Defective Device; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE A GOOSE NECK SNARE DURING PROCEDURE TO TREAT LESION IN THE RIGHT VENTRICLE (RCA) TO SNARE A NON-MEDTRONIC DEVICE. THE DEVICE WAS USED IN AN INFECTED PATIENT. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS MODERATELY TORTUOUS. THE VESSEL WAS STENOSED. IT WAS REPORTED THAT THE BREAK WAS AT THE JOINT BEFORE THE WIRE WAS DIVIDED INTO THE LOOP PART. THE LOOP PART WAS NOT TORN, BUT TWO WIRES SPLIT INTO TWO FORKS AT THE JUNCTION AND ONE OF THE WIRES WAS BROKEN. IT WAS SAID THAT THE LOOP JUNCTION PART OF THE SNARE WAS ONLY EXTENDED, IT WAS NOT TORN. THERE WAS NO FRAGMENTS LEFT IN THE PATIENT. THE DEVICE WAS REMOVED AND A NON MEDTRONIC SNARE WAS USED TO COMPLETED PROCEDURE. IT WAS REPORTED THAT THE JUNCTION WERE THE LOOPED WIRE WAS SEPARATED IN TOW PARTS. IT SEEMED THE WIRE ON ONE PART WAS BROKEN. THE SNARE WIRE WAS SPLIT/SEPARATED. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. THERE WAS NO INTERVENTION REQUIRED TO REMOVE THE SNARE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10090949 ↗
• InjuryJun 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE BLOOD FLOW AND REMAINED IN THE DISTAL REGION OF THE CORONARY ARTERY. THERE WAS NO BLOOD NOTED FLOW IN THE CIRCUMFLEX.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8694931 ↗
• InjuryMay 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN WAS USING A GOOSENECK SNARE FOR TREATMENT. THE DEVICE WAS PREPPED WITH NO ISSUES. IT WAS REPORTED THAT THE MARKER BAND DETACHED FROM THE CATHETER WHILE IT WAS INSIDE THE PATIENT. THE MARKER BAND WAS CAGED TO THE VESSEL WALL USING A STENT. NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8586001 ↗
• InjuryFeb 15, 2018Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO IMPLANT OF A MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVE INTO A BICUSPID VALVE. IT WAS REPORTED THAT DURING THIS PROCEDURE, THE VALVE DISLODGED DURING THE FINAL RELEASE. THE VALVE WAS SNARED INTO THE ASCENDING AORTA AND A SECOND VALVE WAS IMPLANTED. THE FIRST VALVE WAS UNSTABLE IN THE ASCENDING AORTA AND WAS REPEATEDLY PULLED UPWARD WITH TWO SNARES. THE SNARE BECAME STUCK AND THE VALVE WAS FORCEFULLY PULLED TO THE DESCENDING AORTA. THE VALVE WAS ATTEMPTED TO BE COLLECTED WITH A 20FR SHEATH IN THE ABDOMINAL REGION, BUT WAS UNSUCCESSFUL. THE SNARE AND FIRST VALVE WERE SUBSEQUENTLY REMOVED VIA LAPAROTOMY. UPON INSPECTION, THE METAL TIP OF THE MEDTRONIC SNARE SHEATH HAD DETACHED, WHICH TIGHTENED THE SNARE TIP CATCHING THE PADDLE OF THE VALVE. THE VALVE WAS COVERED WITH THROMBUS AND INTIMAL TISSUE. THE REPORTED ACT (ACTIVATED CLOTTING TIME) LEVELS WERE 250 SECONDS OR GREATER THROUGHOUT THE PROCEDURE. DISSECTION WAS NOTED IN THE AORTIC ARCH AND WAS MONITORED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. ONE DAY FOLLOWING THE PROCEDURE, A CEREBRAL INFARCTION OCCURRED. REHABILITATION HAS BEEN PRESCRIBED. NO OTHER ADVERSE PATIENT EFFECTS

  Patient problems: Device Embedded In Tissue or Plaque; Infarction, Cerebral

  MAUDE report 7272609 ↗
• MalfunctionJan 13, 2017Break; Break

  PHYSICIAN WAS ATTEMPTING TO USE A GOOSENECK SNARE TO CAPTURE A STRETCHED COIL IN THE HEPATIC ARTERY. IT WAS REPORTED THAT THE WIRE SHAFT OF THE SNARE DEVICE BROKE DURING THE PROCEDURE. ANOTHER SNARE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED BY LESS THAN 30 MINUTES. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6248483 ↗

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