Swift Coil System 400SWPC45-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00815948029576), received between Sep 27, 2024 and Sep 29, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (8 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.

• MalfunctionSep 29, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927760 ↗
• MalfunctionFeb 20, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING SWIFTPAC COILS (SWIFTPACS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SWIFTPAC TO THE TARGET LOCATION USING THE MICROCATHETER. WHILE RETRACTING THE SWIFTPAC TO REPOSITION IT, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE COIL HAD UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE MICROCATHETER AND PARTIALLY IN THE ANEURYSM. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE DETACHED SWIFTPAC. THE PHYSICIAN THEN ADVANCED A SECOND SWIFTPAC OF A DIFFERENT SIZE TO THE TARGET LOCATION USING THE SAME MICROCATHETER. WHILE RETRACTING THE SWIFTPAC TO REPOSITION IT, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE COIL HAD UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE MICROCATHETER AND PARTIALLY IN THE ANEURYSM. THE PHYSICIAN THEN USED A STENT RETRIEVER TO REMOVE THE SWIFTPAC FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND ANOTHER SWIFTPAC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405691 ↗
• MalfunctionAug 14, 2025Fracture; Premature Separation; Fracture; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE MENINGEAL ARTERY (MMA) USING A SWIFTPAC COIL (SWIFTPAC), A MIDWAY 43 DELIVERY CATHETER (MIDWAY 43), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE RETRACTING THE SWIFTPAC TO REPOSITION IT, THE SWIFTPAC UNINTENTIONALLY DETACHED PARTIALLY IN THE MIDWAY 43 AND PARTIALLY IN THE TARGET VESSEL. THE SWIFTPAC PUSHER ASSEMBLY AND MICROCATHETER WERE REMOVED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DETACHED EMBOLIZATION COIL USING A NON-PENUMBRA STENT AND IT FRACTURED. IT WAS REPORTED THAT A SEGMENT OF THE FRACTURED EMBOLIZATION COIL WAS REMOVED USING THE STENT AND THE REMAINING SEGMENT WAS PUSHED INTO THE TARGET VESSEL USING A GUIDEWIRE (0.035). 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 22812021 ↗
• InjuryJun 9, 2025Premature Separation; 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 GUIDE CATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SWIFTPAC COIL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE SWIFTPAC COIL WAS TOO LONG FOR THE VESSEL AND DECIDED TO REMOVE THE COIL. WHILE RETRACTING THE SWIFTPAC COIL, THE SWIFTPAC COIL HAD UNINTENTIONALLY DETACHED. THE PHYSICIAN ATTEMPTED TO PUSH THE DETACHED SWIFTPAC COIL INTO THE VESSEL USING THE PUSHER ASSEMBLY, BUT THE COIL WAS TOO LARGE AND COULD NOT BE PUSHED ALL THE WAY INTO THE VESSEL. THEREFORE, THE PHYSICIAN USED A WIRE TO PUSH MOST OF THE DETACHED SWIFTPAC COIL INTO THE VESSEL WITH SOME OF THE COIL REMAINING MAXILLARY ARTERY. THE PHYSICIAN DETERMINED IT WAS SAFE TO LEAVE THE DETACHED SWIFTPAC COIL PARTIALLY IN THE MAXILLARY ARTERY. THE PROCEDURE HAD ENDED AT THIS POINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22167978 ↗
• MalfunctionDec 4, 2024Physical Resistance/Sticking; Premature Separation; Physical 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. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE SWIFTPAC INTO THE TARGET LOCATION, THE PHYSICIAN DETERMINED THAT THE SWIFTPAC WAS TOO LONG FOR THE TARGET VESSEL. THE PHYSICIAN DECIDED TO REMOVE THE SWIFTPAC FOR A SHORTER SWIFTPAC. WHILE RETRACTING THE SWIFTPAC, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE SWIFTPAC UNINTENTIONALLY DETACHED IN THE COMMON CAROTID ARTERY (CCA). THE PHYSICIAN THEN USED A BALLOON TO PUSH THE SWIFTPAC INTO THE EXTERNAL CAROTID ARTERY (ECA). THE PHYSICIAN DETERMINED THAT THE SWIFTPAC WAS SAFE TO BE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND THE SAME MICROCATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 20844478 ↗
• MalfunctionNov 27, 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 TWO SWIFTPAC COILS (SWIFTPACS), A BENCHMARK BMX96 ACCESS SYSTEM (BMX96), A MIDWAY 62 DELIVERY CATHETER (MIDWAY 62), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE THE SWIFTPAC INTO THE TARGET VESSEL, BUT THE SWIFTPAC WAS TOO LONG FOR THE TARGET VESSEL. THE PHYSICIAN DECIDED TO REMOVE THE SWIFTPAC. WHILE RETRACTING THE SWIFTPAC, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SWIFTPAC UNINTENTIONALLY DETACHED IN THE INTERIOR MAXILLARY ARTERY (IMA). IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO LEAVE THE SWIFTPAC IN THE IMA AS THERE WAS NO RISK TO THE PATIENT. WHILE ADVANCING ANOTHER SWIFTPAC THROUGH THE SAME MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE SWIFTPAC WOULD NOT ADVANCE THROUGH THE MICROCATHETER. THEREFORE, THE SECOND SWIFTPAC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS, THE SAME BMX96, THE SAME MIDWAY 62, THE SAME MICROCATHETER, AND THE SAME GUIDEWIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20798905 ↗
• MalfunctionNov 4, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR MIDDLE MENINGEAL ARTERY (MMA) USING A SWIFTPAC COIL (SWIFTPAC), A NEURON SELECT CATHETER 6F (6F SELECT), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA SHEATH, AND A MICROWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SWIFTPACS INTO THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A THIRD SWIFTPAC THREE FOURTH OF THE WAY INTO THE TARGET LOCATION AND DECIDED TO REPOSITION THE MICROCATHETER INTO THE POSTERIOR BRANCH OF THE MMA. WHILE RETRACTING THE THIRD SWIFTPAC BACK INTO THE MICROCATHETER, THE THIRD SWIFTPAC UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE THIRD SWIFTPAC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL SWIFTPACS, THE SAME 6F SELECT, THE SAME MICROCATHETER, THE SAME SHEATH, AND THE SAME MICROWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20605652 ↗
• MalfunctionSep 27, 2024Fracture; Material Deformation; Premature Separation; Fracture; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING SWIFTPAC COILS (SWIFTPAC), A MIDWAY 43 DELIVERY CATHETER (MIDWAY 43), NON-PENUMBRA MICROCATHETERS, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO SWIFTPAC COILS. WHILE ADVANCING THE NEXT SWIFTPAC COIL THROUGH THE MICROCATHETER, THE PHYSICIAN KINKED THE SWIFTPAC COIL PUSHER ASSEMBLY. SUBSEQUENTLY, THE SWIFTPAC COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE MICROCATHETER, AND PARTIALLY IN THE PATIENT¿S VESSEL. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER FROM THE PATIENT. A NEW MICROCATHETER AND A STENT RETRIEVER WERE ADVANCED TO ATTEMPT TO REMOVE THE DETACHED SWIFTPAC COIL. WHILE RETRACTING THE STENT RETRIEVER, THE SWIFTPAC COIL FRACTURED INSIDE THE MICROCATHETER AND THE REMAINING PART OF THE COIL REMAINED IN THE PATIENT¿S MMA. THE PHYSICIAN THEN USED THE MICROCATHETER TO PUSH THE SWIFTPAC COIL TO THE DESIRED LOCATION IN THE VESSEL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SWIFTPAC COILS, AND THE FIRST NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20328586 ↗