Swift Coil System 400SWPC03-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948024779), received between Mar 27, 2025 and Jun 3, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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.

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.

• MalfunctionJun 3, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT MIDDLE MENINGEAL ARTERY (MMA) USING SWIFTPAC COILS (SWIFTPAC), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. THE PHYSICIAN SUCCESSFULLY PLACED FOUR SWIFTPAC COILS INTO THE TARGET VESSEL. WHILE ATTEMPTING TO PLACE THE NEXT SWIFTPAC, THE PHYSICIAN DECIDED TO REMOVE AND RESHEATH THE SWIFTPAC TO REPOSITION THE MICROCATHETER. THE SWIFTPAC WAS REINTRODUCED INTO THE MICROCATHETER. WHILE ADVANCING THE SWIFTPAC, THE PUSHER ASSEMBLY WAS KINKED AND THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE EMBOLIZATION COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A LIQUID EMBOLIC AGENT AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25376237 ↗
• MalfunctionMar 11, 2026Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING SWIFTPAC COILS, (SWIFTPAC), SWIFT COIL DETACHMENT HANDLES (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SWIFTPAC INTO THE TARGET LOCATION AND USED THE SWIFT HANDLE TO DETACH THE EMBOLIZATION COIL. HOWEVER, WHEN THE PHYSICIAN WENT TO REMOVE THE PUSHER ASSEMBLY, THE SWIFTPAC WAS STILL ATTACHED. THE PHYSICIAN ATTEMPTED TO DETACH THE SWIFTPAC USING A SECOND SWIFT HANDLE, BUT THE SWIFTPAC WOULD NOT DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SWIFTPAC. WHILE RETRACTING THE EMBOLIZATION COIL BACK INTO THE MICROCATHETER, THE SWIFTPAC HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED A GUIDEWIRE TO PUSH THE DETACHED SWIFTPAC SUCCESSFULLY INTO THE MMA TRUNK. IT WAS REPORTED THAT THE SAME ISSUE HAD OCCURRED AFTER PLACING A SECOND SWIFTPAC AND ATTEMPTING TO DETACH IT USING THE FIRST SWIFT HANDLE. WHILE REMOVING THE SWIFTPAC, THE EMBOLIZATION COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN USED THE SAME GUIDEWIRE TO PUSH THE DETACHED SWIFTPAC INTO THE MMA TRUNK. THE PROCEDURE WAS COMPLET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569080 ↗
• MalfunctionMar 27, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR LINGUAL ARTERY (ILA) USING A SWIFTPAC COIL (SWIFTPAC), A NON-PENUMBRA MICROCATHETER, AND A ROTATING HEMOSTASIS VALVE (RHV). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE SWIFTPAC INTO THE TARGET LOCATION. THE PHYSICIAN ATTEMPTED TO PLACE ANOTHER SWIFTPAC INTO THE TARGET LOCATION, BUT THE SWIFTPAC WOULD NOT PACK. THE PHYSICIAN DECIDED TO RETRACT THE SWIFTPAC TO REPOSITION THE MICROCATHETER. IT WAS REPORTED THAT THE SWIFTPAC WAS PULLED THROUGH THE RHV PRIOR TO RETRACTING BACK INTO ITS SHEATH. IT WAS NOTED THAT THE SWIFTPAC DID NOT APPEAR TO BE DAMAGED DURING INSPECTION. WHILE ADVANCING THE SWIFTPAC INTO THE MICROCATHETER, THE SWIFTPAC UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED THE SWIFTPAC PUSHER ASSEMBLY TO PUSH THE DETACHED SWIFTPAC INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ANOTHER SWIFTPAC, THE SAME MICROCATHETER, AND THE SAME RHV. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21714410 ↗