AMPLATZ GOOSE NECK™ GN1000 (UDI 00763000225247)Recalls & reported problems
Ev3, Inc · SNARE GN1000 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000225247), received between Feb 23, 2022 and Feb 23, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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
Device problems
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 23, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN WAS ATTEMPTING TO USE THE GOOSENECK SNARE DURING PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT PART OF THE PRODUCT FELL OFF AND IS EMBEDDED IN THE PULMONARY ARTERY. THE DEVICE FRAGMENT REMAINS IN PATIENT THE TIP PART OF SNARE SEEMED TO HAVE BEEN CUT OFF WITHOUT ANY RESISTANCE. PATIENT STATUS IS ALIVE WITH INJURY. PATIENT HAS BEEN DISCHARGED WITHOUT LIFE-THREATENING EFFECT, BUT SURGERY IS NEEDED TO REMOVE THE DEVICE FRAGMENT LEFT IN THE PATIENT'S BODY.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 13584287 ↗
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
Other Catheter, embolectomy devices
- Indigo System CAT6Penumbra, Inc. · CATHETER, EMBOLECTOMY2 deaths408 reports
- Indigo System CATRXKITPenumbra, Inc. · Catheter, Embolectomy1 death339 reports
- Fogarty 120804FPEdwards Lifesciences LLC · Catheter, Embolectomy1 recall1 death200 reports
- LeMaitre Embolectomy Catheter 1651-88Lemaitre Vascular, Inc. · Catheter, Embolectomy1 recall161 reports
- FOGARTY 120404FPEdwards Lifesciences LLC · Catheter, Embolectomy1 recall61 reports
- Indigo System CAT6KIT-APenumbra, Inc. · Catheter, Embolectomy109 reports
- LeMaitre Embolectomy Catheter e1651-88Lemaitre Vascular, Inc. · Catheter, Embolectomy2 recalls4 reports
- Indigo System CAT8XTORQ115Penumbra, Inc. · CATHETER, EMBOLECTOMY2 deaths98 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page