Swift Coil System 400SWPC06-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948029514), received between Oct 29, 2024 and Sep 10, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718547 ↗
• MalfunctionSep 4, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A SWIFTPAC COIL (SWIFTPAC), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SWIFTPAC THROUGH THE MICROCATHETER AND NOTICED THAT THE BLACK DETACHMENT ZONE OF THE PUSHER ASSEMBLY WAS SEPARATED. THE PHYSICIAN THEN OBSERVED UNDER FLUOROSCOPY THAT THE SWIFTPAC HAD UNINTENTIONALLY DETACHED AND WAS PARTIALLY OUT OF THE MICROCATHETER. THE PHYSICIAN THEN USED THE GUIDEWIRE TO PUSH THE DETACHED SWIFTPAC OUT OF THE MICROCATHETER AND INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ANOTHER SWIFTPAC, THE SAME MICROCATHETER, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963823 ↗
• MalfunctionOct 29, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE FRONTAL TRUNK OF THE MIDDLE MENINGEAL ARTERY (MMA) USING SWIFTPAC COILS (SWIFTPAC) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, AFTER ADVANCING THE FIRST SWIFTPAC COIL INTO THE TARGET VESSEL, THE PHYSICIAN DECIDED TO ADJUST THE COIL. HOWEVER, WHILE PULLING BACK ON THE SWIFTPAC COIL TO STRAIGHTEN OUT THE COIL INSIDE THE MICROCATHETER, THE COIL HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT A PORTION OF THE SWIFTPAC COIL WAS IN THE COMMON TRUNK OF THE MMA. THEREFORE, THE PHYSICIAN USED A MICRO WIRE TO PUSH THE DETACHED SWIFTPAC COIL BACK INTO THE FRONTAL AND PARIETAL OF THE MMA AND THE COIL WAS SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563545 ↗