Swift Coil SystemRecalls & reported problems across all models

We found 11 models of Swift Coil System by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 51 adverse event reports in the FDA's MAUDE database, received between Sep 6, 2024 and Sep 29, 2026 — classified as 5 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (47 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Swift Coil System problems

Swift Coil System models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Swift Coil System 400SWPC30-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  13 reports
• Swift Coil System 400SWPC10-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  8 reports
• Swift Coil System 400SWPC45-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  8 reports
• Swift Coil System 400SWPC60-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  7 reports
• Swift Coil System 400SWPC03-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Swift Coil System 400SWPC06-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Swift Coil System 400SWPC15-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Swift Coil System 400SWPC20-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• Swift Coil System 400SWCCL202-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Swift Coil System 400SWCCL306-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• Swift Coil System 400SWPC25-A

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report

Recent Swift Coil System adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 29, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50927755 ↗
• MalfunctionSep 10, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718547 ↗
• MalfunctionSep 2, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564525 ↗
• 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 ↗
• MalfunctionApr 3, 2026Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A SWIFTSET COIL (SWIFTSET) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE SWIFTSET INTO THE TARGET LOCATION. THE PHYSICIAN ADVANCED ANOTHER SWIFTSET, BUT NOTICED THAT THE MICROCATHETER NEEDED TO BE REPOSITIONED PRIOR TO PLACING THE COIL. WHILE RETRACTING THE SWIFTSET, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SWIFTSETS 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 24783878 ↗
• 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 ↗
• 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 ↗
• 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 23, 2026Premature 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 PHYSICIAN ADVANCED A SWIFTPAC INTO THE TARGET VESSEL. WHILE REPOSITIONING THE MICROCATHETER AND SWIFTPAC, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE TARGET VESSEL. THE PHYSICIAN USED A SYRINGE TO ASPIRATE THE DETACHED EMBOLIZATION COIL INTO THE MICROCATHETER AND THE MICROCATHETER CONTAINING THE COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW SWIFTPAC COIL 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 24416696 ↗
• 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 ↗
• 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 24405676 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 30, 2026Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BILATERAL MIDDLE MENINGEAL ARTERIES (MMA) USING SWIFTPAC COILS (SWIFTPAC), A SWIFT COIL DETACHMENT HANDLE, MIDWAY 43 DELIVERY CATHETER (MIDWAY 43), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN DETACHED FOUR SWIFTPACS IN THE RIGHT MMA USING THE HANDLE. THE PHYSICIAN THEN ADVANCED A FIFTH SWIFTPAC TO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SWIFTPAC COIL DID NOT DETACH. THE PHYSICIAN SUBSEQUENTLY USED HEMOSTATS TO MANUALLY DETACH THE COIL. THE PHYSICIAN PLACED THREE SWIFTPAC COILS IN THE LEFT MMA USING THE MICROCATHETER AND MIDWAY 43. A FOURTH SWIFTPAC WAS THEN SUCCESSFULLY DETACHED AT THE TARGET LOCATION. AFTER REMOVAL OF THE MICROCATHETER FROM THE TARGET VESSEL, THE SWIFTPAC COIL WAS OBSERVED TO BE WITHIN THE MIDWAY 43 CATHETER. THE MIDWAY 43 CONTAINING THE DETACHED COIL WAS THEN REMOVED FROM THE PATIENT. IT WAS REPORTED THAT A PORTION OF THE COIL MAY HAVE BEEN WITHIN THE MICROCATHETER AT THE TIME OF DETACHMENT, AND THAT REMOVAL OF THE MICROCATHETER MAY HAVE CONTRIBUTED TO MOVEMENT OF THE COIL INTO THE MIDWAY 43. IT WAS ALSO REPORTED THAT THE MIDWAY 43 CATHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226658 ↗

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