SIEGE™ Initial Release (REF SVP2.5-0.021)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00884450815908), received between Aug 5, 2025 and May 26, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (6 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2026Activation, Positioning or Separation Problem

  THE CUSTOMER REPORTED THAT THEY TRIED TO DEPLOY A SIEGE VASCULAR PLUG AND IT DID NOT DEPLOY. THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25281027 ↗
• MalfunctionMay 26, 2026Activation, Positioning or Separation Problem

  THE CUSTOMER REPORTED THAT THE PLUG DIDN'T DEPLOY PROPERLY AND FELL OUT OF THE HOOP AND BECAME UNSTERILE. THERE WAS NO REPORTED PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280153 ↗
• MalfunctionMay 26, 2026Activation, Positioning or Separation Problem

  THE CUSTOMER REPORTED THAT WHILE DOING AN IN-SERVICE FOR THE SIEGE VASCULAR PLUG AND AFTER PREPPING THE PLUG, THE PHYSICIAN INSERTED THE PLUG INTO THE CATHETER AND STARTED TO PUSH. THE SIEGE PLUG BECAME STUCK AND AFTER MANY UNSUCCESSFUL ATTEMPTS TO ADVANCE THE PLUG, THE PHYSICIAN PULLED IT BACK OUT OF THE CATHETER, WHERE IT WAS DISCOVERED THAT THE DISTAL TIP STARTED TO CURL UP. THERE WAS NO REPORTED PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280144 ↗
• MalfunctionApr 16, 2026Activation, Positioning or Separation Problem

  THE CUSTOMER REPORTS WHILE DOING AN IN-SERVICE FOR THE SIEGE VASCULAR PLUG AND AFTER PREPPING THE PLUG, THE PHYSICIAN INSERTED THE PLUG INTO THE CATHETER AND STATED TO PUSH. THE SIEGE PLUG BECAME STUCK AND AFTER MANY UNSUCCESSFUL ATTEMPTS TO ADVANCE THE PLUG, THE PHYSICIAN PULLED IT BACK OUT OF THE CATHETER, WHERE IT WAS DISCOVERED THAT THE DISTAL TIP STARTED TO CURL UP.THE ANATOMY WAS NOT TORTUROUS. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905886 ↗
• MalfunctionApr 16, 2026Activation, Positioning or Separation Problem

  THE CUSTOMER REPORTS THEY TRIED TO DEPLOY A SIEGE VASCULAR PLUG AND IT DID NOT DEPLOY. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901271 ↗
• MalfunctionApr 16, 2026Activation, Positioning or Separation Problem

  THE CUSTOMER REPORTS THE PLUG DIDN'T DEPLOY PROPERLY. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901270 ↗
• MalfunctionAug 5, 2025Lack of Effect; Lack of Effect

  THE ACCOUNT ALLEGES TWO SIEGE DEVICES WERE SUCCESSFULLY PLACED IN AN 8 MONTH OLD PATIENT. DURING THE PROCEDURE THE COLLATERAL WAS SIZED MANY TIMES AND DETERMINED TO BE 3.7MM. AFTER REVIEW A 6.5MM SIEGE PLUG WAS USED ALONGSIDE A CORRECTLY SIZED TERUMO PROGREAT. THE DEVICE WAS PREPPED AND PLACED SUCCESSFULLY AROUND A CURVE. ONCE THE DEVICE WAS IN A GOOD POSITION IT WAS DEPLOYED, GOOD VIEW OF THE RADIOPAQUE MARKERS AND LOBES WAS VISIBLE. FLOW WAS STILL NOTICEABLE AT THE TWO MINUTE MARK. AFTER A TOTAL OF 15 MINUTES THE FLOW BECAME NOTICEABLY SLUGGISH. THE SECOND COLLATERAL WAS 2.2MM AND A 4.5MM SIEGE PLUG WAS USED. THE DEVICE WAS PREPPED AND PLACED SUCCESSFULLY. AFTER 20 MINUTES THERE WAS NO CHANGE IN THE FLOW THROUGH THE COLLATERAL. THE CLINICIAN DECIDED TO KEEP THE DEVICE IN AND WILL CHECK ON IT AFTER SOME TIME. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22717359 ↗