AMPLATZ GOOSE NECK™ SK400Recalls & reported problems
Ev3, Inc · SNARE SK400 MICRO SNARE V01 · Class 2
All models of AMPLATZ GOOSE NECK (10)
Data updated Oct 18, 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 00763000225391), received between Nov 18, 2024 and Nov 18, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Damaged by Another Device1
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 18, 2024Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device
A PHYSICIAN WAS ATTEMPTING TO USE A NON-MEDTRONIC (ABBOTT) STENT TO TREAT A PATIENT. THE VESSEL WAS PRE AND POST DILATED. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. REMOVAL DIFFICULTIES WAS REPORTED, A SNARE WAS STUCK ON A STENT IN THE PATIENT, IT BROKE SO THE LOOP PORTION IS TACKED AGAINST THE VESSEL WALL WITH A VBX. TO REMOVE, PULLED WITH RESISTANCE, REMOVED SUCCESSFULLY IN TANDEM WITHOUT INJURY/INTERVENTION. NO VESSEL DAMAGE REPORTED. PROCEDURE ABORTED, NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20707225 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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