AMPLATZ GOOSE NECK SK700Recalls & reported problems
Covidien LP · Microsnare Kit · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821684005033), received between Mar 28, 2018 and Mar 28, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Distortion” (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 18, 2026.
Most reported problems
Device problems
- Material Distortion1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2018Material Distortion; Material Distortion
THE PHYSICIAN WAS USING A MICROSNARE DEVICE WITH A NON-MDT GUIDEWIRE, NON-MDT 6F GUIDING CATHETER AND NON-MDT 6F, Y ADAPTOR, AND Y CONNECTOR DURING A FOREIGN BODY RETRIEVAL PROCEDURE. THE DEVICE WAS PREPPED AS PER IFU WITHOUT ISSUE. IT WAS REPORTED THAT WHEN THE PHYSICIAN BEGAN TO INSERT THE DEVICE, THE SNARE WIRE COATING WAS OBSERVED TO BE PARTIALLY PEELED AND DIFFICULTY WAS EXPERIENCED WHEN ATTEMPTING TO INSERT. THE DEVICE WAS REPLACED WITH A NEW MICROSNARE TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUE. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7376643 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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