Swift Coil System 400SWPC30-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00815948029569), received between Dec 12, 2024 and Sep 2, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (13 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564525 ↗
• MalfunctionFeb 5, 2026Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAROTID CAVERNOUS FISTULA (CCF) USING A SWIFTPAC COIL (SWIFTPAC), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE SWIFTPAC THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER AND PARTIALLY IN THE PATIENT'S VESSEL. IT WAS REPORTED THAT THE SWIFTPAC PUSHER ASSEMBLY WAS KINKED. A SNARE DEVICE WAS USED TO REMOVE THE DETACHED EMBOLIZATION COIL. THE PROCEDURE 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 24269448 ↗
• MalfunctionOct 24, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A SWIFTPAC COIL (SWIFTPAC). IT WAS REPORTED THAT THE SWIFTPAC COIL DETACHED. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23386422 ↗
• MalfunctionAug 29, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE MENINGEAL ARTERY (MMA) USING A SWIFTPAC COIL (SWIFTPAC), A SWIFT COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED EMBOLIC AGENT IN THE TARGET LOCATION. THE PHYSICIAN ADVANCED A SWIFTPAC COIL IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE, BUT THE SWIFTPAC COIL FAILED TO DETACH. THE SWIFTPAC COIL PUSHER ASSEMBLY HAD SEPARATED BUT, THE EMBOLIZATION COIL WAS STILL ATTACHED. THE PHYSICIAN MADE SEVERAL ATTEMPTS ADVANCING AND RETRACTING THE SWIFTPAC TO DETACH IT BUT WAS UNSUCCESSFUL. WHILE REMOVING THE SWIFTPAC COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SWIFTPAC COIL DETACHED. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE SWIFTPAC COIL TO PUSH THE DETACHED COIL SUCCESSFULLY INTO THE TARGET LOCATION. THE PROCEDURE TO TREAT THE RIGHT MMA WAS COMPLETED AND THE REMAINDER OF THE PROCEDURE TO TREAT THE LEFT MMA WAS COMPLETED USING ADDITIONAL SWIFTPAC COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929430 ↗
• InjuryAug 10, 2025Fracture; Premature Separation; Fracture; Premature Separation

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A SWIFTPAC COIL (SWIFTPAC), A LIQUID EMBOLIC AGENT, A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE LIQUID EMBOLIC AGENT WAS PLACED IN THE DISTAL FRONTAL BRANCH OF THE MMA. THE PHYSICIAN BEGAN TO ADVANCE THE SWIFTPAC OUT OF THE MICROCATHETER INTO THE PARIETAL AND FRONTAL BRANCH OF THE MMA. AS THE SWIFTPAC WAS BEING POSITIONED, THE PHYSICIAN LOST FEEDBACK AND THE SWIFTPAC DID NOT RESPOND TO FORCE ON THE PUSHER WIRE. FLUOROSCOPIC IMAGING REVEALED THAT THE SWIFTPAC WAS IN THE MAIN TRUNK OF THE MMA TO THE EXTERNAL CAROTID ARTERY (ECA). THE PHYSICIAN THEN REMOVED THE MICROCATHETER AND THE BENCHMARK UNDER ASPIRATION TO TRY AND REMOVE THE DETACHED SWIFTPAC. THE PUSHER WAS ALSO REMOVED. A FRACTURED PROXIMAL SWIFTPAC PIECE WAS NOTED TO BE IN THE INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN REMOVED THE PROXIMAL SWIFTPAC PIECE USING A SNARE DEVICE. THE PHYSICIAN DECIDED TO LEAVE THE DISTAL PIECE OF THE SWIFTPAC IN PLACE. THE PROCEDURE ENDED AT THIS POINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22768157 ↗
• MalfunctionJul 30, 2025Premature Separation; 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, THE SWIFTPAC UNINTENTIONALLY DETACHED IN THE TARGET VESSEL. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING A SMALLER SIZE 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 22668649 ↗
• MalfunctionMar 28, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE MIDDLE MENINGEAL ARTERY (MMA) USING AN SWIFTPAC COIL (SWIFTPAC), A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK), A MIDWAY 43 DELIVERY CATHETER (MIDWAY 43), AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT HAD A SUBDURAL HEMATOMA (SDH). DURING THE PROCEDURE, AFTER ADVANCING HALF OF THE SWIFTPAC INTO THE TARGET LOCATION, THE MICROCATHETER HERNIATED DUE TO LACK OF SUPPORT. WHILE MANIPULATING THE SWIFTPAC, THE PHYSICIAN EXPERIENCED RESISTANCE, FELT A POP, AND THE SWIFTPAC UNINTENTIONALLY DETACHED IN THE MMA. IT WAS REPORTED THAT HALF OF THE SWIFTPAC WAS IN THE INTERNAL MAXILLARY ARTERY (IMAX). THE PHYSICIAN ATTEMPTED TO PUSH THE DETACHED SWIFTPAC FROM THE IMAX INTO THE MMA USING THE SWIFTPAC PUSHER ASSEMBLY, BUT THE ATTEMPT WAS NOT SUCCESSFUL. THE PHYSICIAN DECIDED TO LEAVE THE SWIFTPAC AS IT WAS SAFE. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21722158 ↗
• MalfunctionMar 14, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING SWIFTPAC COILS (SWIFTPAC), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SWIFTPAC THROUGH THE MICROCATHETER AND INTO THE TARGET LOCATION. WHILE REPOSITIONING THE MICROCATHETER, THE SWIFTPAC COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN USED A WIRE TO PUSH THE DETACHED SWIFTPAC INTO THE ANEURYSM. THE PROCEDURE WAS CONSIDERED COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21612793 ↗
• MalfunctionMar 14, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING SWIFTPAC COILS (SWIFTPAC), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE REPOSITIONING THE MICROCATHETER, THE SWIFTPAC UNINTENTIONALLY DETACHED IN THE TARGET VESSEL. THE SAME ISSUE OCCURRED WITH THE NEXT SWIFTPAC. THEREFORE, THE PHYSICIAN USED A WIRE TO PUSH THE DETACHED SWIFTPAC COILS TO THE DESIRED LOCATION. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606374 ↗
• MalfunctionMar 14, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING SWIFTPAC COILS (SWIFTPAC), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE REPOSITIONING THE MICROCATHETER, THE SWIFTPAC UNINTENTIONALLY DETACHED IN THE TARGET VESSEL. THE SAME ISSUE OCCURRED WITH THE NEXT SWIFTPAC. THEREFORE, THE PHYSICIAN USED A WIRE TO PUSH THE DETACHED SWIFTPAC COILS TO THE DESIRED LOCATION. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606275 ↗
• MalfunctionFeb 21, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A SWIFTPAC COIL (SWIFTPAC), AND A MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE SWIFTPAC THROUGH THE MICROCATHETER, THE SWIFTPAC UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SWIFTPAC WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW 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 21438930 ↗
• InjuryFeb 4, 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 COIL (SWIFTPAC), A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN DELIVERED MICROSPHERE PARTICLES IN THE TARGET LOCATION. NEXT, THE PHYSICIAN ADVANCED THE FIRST SWIFTPAC COIL THROUGH THE MICROCATHETER BUT DECIDED TO RETRACT THE PUSHER ASSEMBLY TO REPOSITION THE SWIFTPAC COIL. WHILE RETRACTING THE SWIFTPAC COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SWIFTPAC HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THE DETACHED SWIFTPAC COIL WAS PARTIALLY INSIDE THE MICROCATHETER AND PARTIALLY IN THE VESSEL. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER AND USED A GUIDEWIRE (.038) THROUGH THE DIAGNOSTIC CATHETER TO PUSH THE DETACHED SWIFTPAC COIL OUT FROM THE COMMON CAROTID ARTERY INTO THE EXTERNAL CAROTID ARTERY. THE PROCEDURE HAD ENDED AT THIS POINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21305168 ↗
• MalfunctionDec 12, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING SWIFTPAC COIL (SWIFTPAC), MIDWAY 43 DELIVERY CATHETER (MIDWAY 43), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SWIFTPAC COIL PARTIALLY INTO THE VESSEL USING THE MICROCATHETER BUT DECIDED TO RETRACT IT TO REPOSITION THE SWIFTPAC COIL. HOWEVER, WHILE RETRACTING AND THEN READVANCING THE SWIFTPAC COIL, THE PHYSICIAN NOTICED THE SWIFTPAC COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO PUSH THE DETACHED SWIFTPAC COIL USING THE PUSHER ASSEMBLY, BUT IT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN USED THE MICROCATHETER AND MIDWAY 43 TO PUSH THE DETACHED SWIFTPAC COIL INTO THE TARGET VESSEL. 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 20913678 ↗