AMPLATZ GOOSE NECK SK400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821684005026), received between Apr 11, 2018 and May 28, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE SK400 MICRO SNARE, AN ISSUE OCCURRED WHEN ONE END OF THE SNARE COIL/LOOP CAME OFF THE WIRE AS THE PHYSICIAN PULLED THE SNARE THROUGH THE SHEATH ON REMOVAL FROM THE PATIENT. THE PROCEDURE WAS INTENDED TO TREAT A CALCIFIED LESION IN THE PROXIMAL LEFT BRACHIAL. THE VESSEL DIAMETER WAS SPECIFIED AS 7MM. THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22094349 ↗
• MalfunctionJul 13, 2020Defective Device; Material Deformation; Defective Device; Material Deformation

  PHYSICIAN WAS ATTEMPTING TO USE A MICRO SNARE DURING PROCEDURE. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS MODERATELY TORTUOUS. THE MICROSNARE WAS NOT USED TO SNARE A MEDTRONIC DEVICE. THE SNARE WAS EXTENDED DURING THE PROCEDURE. THE DEVICE BROKE DURING TRACTION WHEN HOOKING THE GUIDEWIRE, WHICH WAS ADVANCED FROM RETROGRADE OF BELOW-KNEE ARTERY. THE PHYSICIAN REPORTED THAT THE SNARE WAS EXTENDED DURING THE PROCEDURE, ONE SIDE OF THE JOINT PART OF SNARE ANNULUS WAS BROKEN REPORTEDLY WHEN CONFIRMING THE DETAILED INFORMATION. SINCE IT WAS A BROKEN ISSUE OF ONE SIDE OF THE JOINT PART OF ANNULUS, NOTHING DETACHED AND NOTHING REMAINED INSIDE THE PATIENT'S BODY. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT BY BEING PULLED IN THE PARENT NON-MEDTRONIC SHEATH AND WAS RETRIEVED. THERE WAS NO VESSEL DAMAGE REPORTED. AFTER THE SNARE WAS RETRACTED, THE PROCEDURE WAS COMPLETED USING A NON MEDTRONIC SNARE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10262929 ↗
• InjuryNov 29, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED DURING TREATMENT OF AN ARTERIOVENOUS MALFORMATION (AVM), WITH ADMITTING FEEDER FROM LEFT SUPERIOR CEREBELLAR ARTERY (SCA) DUE TO A BLEEDING EPISODE. A NON-MEDTRONIC CATHETER BECAME ENTRAPPED WITHIN AN ONYX CAST DURING ATTEMPTED REMOVAL. PATIENT¿S ANATOMY WAS DESCRIBED AS BEING SEVERE AND SMALL IN DIAMETER. THE NON-MEDTRONIC CATHETER WAS REPORTED TO HAVE SEPARATED RESULTING IN THE ONYX TO EMBED INTO AN UNINTENDED LOCATION. DUE TO THE MANIPULATIONS REQUIRED TO REMOVE THE NON-MEDTRONIC CATHETER A HAEMORRHAGE WAS NOTED TO HAVE OCCURRED. IT HAS ALSO BEEN REPORTED THAT A GOOSENECK SNARE WAS USED AND DEPLOYED. IT WAS REPORTED THAT THE GOOSENECK SNARE BROKE WHEN IT WAS PULLED WITH FORCE. THE PHYSICIAN PULLED THE DEVICE WITH A STRONG FORCE, BUT DID NOT INTEND TO BREAK IT. PROTAMINE WAS ADMINISTERED TO STOP THE BLEEDING AND THE OPERATION WAS STOPPED FOR 10 MINUTES. HEMOSTASIS WAS PERFORMED AND NO INCREASE BLEEDING WAS OBSERVED. THE RING SHAPED PART OF THE GOOSENECK SNARE WAS PRESSED UP AGAINST THE BLOOD VESSEL WALL USING A NON-MEDTRONIC MICROCATHETER AND THE PROCEDURE WAS COMPLETED. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: Device Embedded In Tissue or Plaque; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8115362 ↗
• MalfunctionApr 11, 2018Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A MICROSNARE TO SNARE AN 0.014" GLADIUS WIRE RUNNING RETROGRADLY FROM THE FOOT IN THE MID DISTAL RIGHT SFA. THE LESION WAS DESCRIBED AS A 3MM DIAMETER, MODERATELY CALCIFIED, MODERATELY TORTUOUS CHRONIC TOTAL OCCLUSION(CTO). THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES IDENTIFIED. MULTIPLE ATTEMPTS WERE PERFORMED HOWEVER THEY WERE ALL UNSUCCESSFUL. WHEN THE SNARE WAS REMOVED FROM THE BODY IT WAS NOTED THAT THE LOOP WAS BROKEN. THE SNARE REMAINED INTACT AND NO FRAGMENTS WERE BROKEN INTO THE PATIENT. AN ALTERNATE SNARE WAS UTILIZED AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7420699 ↗