Swift Coil System 400SWPC10-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00815948029545), received between Dec 6, 2024 and Mar 11, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 24569109 ↗
• MalfunctionFeb 27, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ARTERIOVENOUS (AV) FISTULA ARTERY USING SWIFTPAC COILS (SWIFTPAC), PENUMBRA COIL 400S, PAC400 COILS, NON-PENUMBRA COILS, A MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO NON-PENUMBRA COILS, TWO SWIFTTPAC COILS, TWO PENUMBRA COIL 400S, AND THREE PAC400 COILS INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT SWIFTPAC, THE SWIFTPAC UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED SWIFTPAC WAS REMOVED. THE SWIFTPAC WAS REMOVED FROM THE MICROCATHETER OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL 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 24476724 ↗
• MalfunctionFeb 6, 2026Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A SWIFTPAC COIL (SWIFTPAC), A NON-PENUMBRA COIL, AND A MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE FIRST SWIFTPAC COIL THROUGH THE MICROCATHETER, THE EMBOLIZATION COIL BECAME STUCK INSIDE THE MICROCATHETER AND WOULD NOT ADVANCE FAR ENOUGH INTO THE PATIENT TO BE VISUALIZED UNDER FLUOROSCOPY. THE PHYSICIAN REMOVED THE PUSHER ASSEMBLY OF THE SWIFTPAC COIL UNDER THE ASSUMPTION THAT THE EMBOLIZATION COIL REMAINED ATTACHED. THE PHYSICIAN ADVANCED A NON-PENUMBRA COIL THROUGH THE MICROCATHETER; HOWEVER, THE SAME ISSUE OCCURRED, AND THE COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW SWIFTPAC COIL, BUT THE COIL WOULD NOT ADVANCE THROUGH THE MICROCATHETER. IT WAS REPORTED THAT THE PHYSICIAN NOTICED THE INITIAL SWIFTPAC COIL HAD UNINTENTIONALLY DETACHED AND WAS STUCK WITHIN THE PROXIMAL END OF THE MICROCATHETER PREVENTING THE SECOND SWIFTPAC COIL FROM ADVANCING THROUGH THE MICROCATHETER. AS A RESULT, THE MICROCATHETER CONTAINING THE DETACHED SWIFTPAC COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL AND A NEW MICROCATHETER. THERE WAS NO REPORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282535 ↗
• MalfunctionJan 6, 2026Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A SWIFTPAC COIL (SWIFTPAC) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE RETRACTING THE SWIFTPAC TO REPOSITION, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED SWIFTPAC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SWIFTPAC 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 23975826 ↗
• MalfunctionJun 27, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING SWIFTPAC COILS (SWIFTPACS), A NON-PENUMBRA MICROCATHETER, AN ANGIOGRAPHIC CATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE ANGIOGRAPHIC CATHETER IN THE RIGHT EXTERNAL CAROTID ARTERY THEN ADVANCED THE MICROCATHETER TO THE TARGET SITE. WHILE ADVANCING A SWIFTPAC THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SWIFT PAC BECAME STUCK. THE PHYSICIAN ATTEMPTED TO ADVANCE THE SWIFTPAC THROUGH THE MICROCATHETER, BUT WAS UNSUCCESSFUL AND DECIDED TO REMOVE THE SWIFTPAC. AFTER REMOVING THE SWIFTPAC, IT WAS NOTED THAT THE EMBOLIZATION COIL WAS NOT ATTACHED TO THE PUSHER ASSEMBLY. THE MICROCATHETER WAS REMOVED FROM THE PATIENT AND NOTICED THE EMBOLIZATION COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL SWIFTPACS AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350583 ↗
• MalfunctionMar 7, 2025Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING SWIFTPAC COILS (SWIFTPAC), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE SWIFTPAC COILS. WHILE ADVANCING THE NEXT SWIFTPAC, THE SWIFTPAC PUSHER ASSEMBLY SLIGHTLY KINKED. THE PHYSICIAN DECIDED TO REMOVE AND RESHEATH THE SWIFTPAC. WHILE RETRACTING, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE SWIFTPAC UNINTENTIONALLY DETACHED IN THE INTENDED VESSEL. THE PHYSICIAN DECIDED TO LEAVE THE SWIFTPAC IN PLACE. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS 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 21551541 ↗
• MalfunctionFeb 21, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT THE LEFT MIDDLE MENINGEAL ARTERY (MMA). DURING THE PROCEDURE, THE PHYSICIAN PLACED MICROSPHERE PARTICLES IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER. THE MICROCATHETER WAS THEN REMOVED AND EXCHANGED TO A NEW MICROCATHETER. THE PHYSICIAN WAS ADVANCING THE SWIFTPAC COIL THROUGH THE MICROCATHETER AND NOTICED THE SWIFTPAC COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SWIFTPAC COIL WAS REMOVED. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437560 ↗
• MalfunctionDec 6, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT MIDDLE MENINGEAL ARTERY (MMA) USING SWIFTPAC COILS (SWIFTPACS), A SWIFT COIL DETACHMENT HANDLE (HANDLE), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A MIDWAY 43 DELIVERY CATHETER (MIDWAY 43), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE MICROCATHETER OVER THE GUIDEWIRE. IT WAS REPORTED THAT THE DISTAL END OF THE GUIDEWIRE FRACTURED IN THE MMA AND WILL NOT BE REMOVED. THE PHYSICIAN THEN ADVANCED A SWIFTPAC INTO THE TARGET LOCATION AND PLACED THE SWIFTPAC INTO THE TARGET LOCATION USING THE HANDLE. IT WAS NOTED THAT THE DETACHMENT ZONE WAS SEPARATED. WHILE RETRACTING THE SWIFTPAC PUSHER ASSEMBLY, THE SWIFTPAC REMAINED INTACT TO THE PUSHER ASSEMBLY. THE PHYSICIAN THEN ADVANCED THE SWIFTPAC BACK INTO TARGET LOCATION AND MANUALLY DETACHED THE SWIFTPAC INTO THE TARGET LOCATION. THE GUIDEWIRE WAS THEN EXCHANGED FOR ANOTHER GUIDEWIRE AND WAS ADVANCED THROUGH THE MICROCATHETER TO THE DIFFERENT BRANCH OF THE MMA. WHILE ADVANCING A SECOND SWIFTPAC INTO THE TARGET LOCATION THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE SWIFTPAC HAD U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20870161 ↗