AMPLATZ GOOSE NECK™ GN2500Recalls & reported problems
Ev3, Inc · SNARE GN2500 GOOSENECK SNARE V01 · Class 2
All models of AMPLATZ GOOSE NECK (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000225285), received between May 17, 2021 and Jul 10, 2025 — classified as 4 injuries, 2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component6
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Device Embedded In Tissue or Plaque1
- Embolism/Embolus1
- Unspecified Tissue Injury1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE GOOSENECK SNARE, THE RADIOPAQUE MARKER ON THE DISTAL END OF THE GOOSENECK SNARE DETACHED AND WAS LEFT IN THE VESSEL. THE DEVICE WAS SAFELY REMOVED, HOWEVER THE RADIOPAQUE MARKER IS ASSUMED TO BE FLOATING IN LEFT ATRIUM. THE PATIENT HAD NO HEALTH CONSEQUENCES OR IMPACT OR INTERVENTION DUE TO THIS EVENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22466639 ↗InjurySep 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN WAS ATTEMPTING TO USE GOOSENECK SNARE DURING TREATMENT OF PATIENTS UPPER LEFT QUADRANT OF CHEST. NO VESSEL TORTUOSITY AND NO VESSEL CALCIFICATION ARE REPORTED. IT WAS REPORTED THAT APPROXIMATELY 4 INCHES OF THE CATHETER TIP BROKE OFF IN UPPER LEFT QUADRANT OF PATIENT CHEST. PATIENT REQUIRED A CT AND A SECOND IR PROCEDURE VENOGRAM REMOVAL OF FOREIGN BODY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17718160 ↗MalfunctionDec 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN WAS USING A GOOSENECK SNARE. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THE SNARE BROKE DURING THE PROCEDURE. UNKNOWN IF THE SNARE DETACHED OR WHICH PART OF THE DEVICE BROKE. NO INTERVENTION NEEDED TO REMOVE THE DEVICE OR ANY PIECES. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16002683 ↗InjuryAug 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN WAS ATTEMPTING TO USE A GOOSENECK SNARE DURING PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. MODERATE RESISTANCE WAS FELT. IT WAS REPORTED THAT THE RADIOPAQUE MARKER LET LOOSE WHILE RETRIEVING A NON-MEDTRONIC FILTER (CORDIS) IN THE PATIENT, BUT THE VENA CAVA FILTER RETRIEVED THE RELEASED RADIOPAQUE MARKER. NO ITEMS ARE LEFT IN THE PATIENT. NO VESSEL DAMAGE NOTED. NO FURTHER PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15318590 ↗InjuryMar 31, 2022Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component
PHYSICIAN WAS ATTEMPTING TO USE THE GOOSENECK SNARE DURING PROCEDURE TO TREAT LITTLE CALCIFIED LESION IN THE MID RIGHT INTERIOR VENA CAVA (IVC). THE VESSEL HAD LITTLE TORTUOSITY AND 0% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES. IT WAS REPORTED THAT THE MARKER BAND ON SNARE CAME OFF DURING NON-MEDTRONIC IVC FILTER REMOVAL AND EMBOLIZED TO PATIENT'S LUNG. FILTER HAD BEEN IMPLANTED IN THE PATIENT FOR SEVERAL YEARS. THE MARKER BAND OR RING DETACHED FROM THE GOOSENECK SNARE OR DELIVERY CATHETER NOT THE FILTER. THE MARKER BAND WAS NOT RETRIEVED. IT HAD EMBOLIZED TO THE LUNG. NO ADVERSE EVENTS WERE REPORTED. PATIENT WAS DISCHARGED AND DOING WELL. NO FURTHER PATIENT INJURY REPORTED.
Patient problems: Device Embedded In Tissue or Plaque; Embolism/Embolus
MAUDE report 13962499 ↗InjuryMay 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN WAS ATTEMPTING TO USE GOOSENECK SNARE DURING PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT THE SNARE BROKE WHILE ATTEMPTING TO USED IT IN A FILTER RETRIEVAL. THE SNARE BROKE OFF THE WIRE, IT SEPARATED OFF WHEN PULLING BACK. ANOTHER SNARE WAS OPENED TO RETRIEVE THE BROKEN SNARE. THE DEVICE WAS SAFELY REMOVED FROM PATIENT. THERE WAS NO VESSEL DAMAGE. THERE WAS NO FURTHER INJURY TO PATIENT.
Patient problems: Unspecified Tissue Injury
MAUDE report 11830626 ↗
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 · TerminatedAmplatz 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
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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