SIEGE™ Initial Release (REF SVP6-0.027)Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450815922), received between Apr 15, 2026 and May 26, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Deformation Due to Compressive Stress2
- Failure to Advance2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Failure to Advance
THE CUSTOMER REPORTED THAT THE SEIGE VASCULAR PLUG WAS UNABLE TO FIT THROUGH A 3.0-2.8 PROGREAT CATHETER. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25280147 ↗MalfunctionMay 26, 2026Material Twisted/Bent
THE CUSTOMER REPORTED THAT THEY WERE ATTEMPTING TO INSERT THE LOADER INTO THE HUB OF MICRO CATHETER AND WHEN ATTEMPTING TO PUSH BEYOND THE HARD STOP, THE TIP OF THE PLASTIC SIEGE PROTECTOR BECAME BENT, AND THE SIEGE WOULD NOT DEPLOY INTO THE MICRO CATHETER. THIS WAS AN EMERGENT RUPTURED SPLENIC ARTERY, AND AN ABBOTT PLUG WAS USED IN PLACE OF MERIT FOR OCCLUSION. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25280141 ↗MalfunctionMay 26, 2026Deformation Due to Compressive Stress
THE CUSTOMER REPORTED THAT THE PHYSICIAN USED A 6.5 INSIDE A .035 BERNSTEIN. THE SIEGE COILED UP ON ITSELF AND KINKED. THIS HAPPENED AFTER GIVING THE INSTRUCTIONS THAT THE SIEGE HAD ONLY BEEN TESTED FOR MICROCATHETER COMPATIBILITY. THERE WAS NO REPORTED PATIENT INJURY AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25280134 ↗MalfunctionApr 15, 2026Failure to Advance
THE CUSTOMER REPORTS THE SIEGE VASCULAR PLUG WAS UNABLE TO FIT THROUGH 3.0-2.8 PROGREAT CATHETER. NO ADDITIONAL DETAILS WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887014 ↗MalfunctionApr 15, 2026Deformation Due to Compressive Stress
THE CUSTOMER REPORTS THE PHYSICIAN USED A 6.5 INSIDE A .035 BERNSTEIN. THE SIEGE COILED UP ON ITSELF AND KINKED. THIS HAPPENED AFTER GIVING THE INSTRUCTION THAT THE SIEGE HAD ONLY BEEN TESTED FOR MICROCATHETER COMPATIBILITY. NO ADDITIONAL DETAILS WERE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887012 ↗
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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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