Swift Coil System 400SWPC60-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00815948029583), received between May 16, 2025 and Sep 29, 2026 — classified as 2 injuries, 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 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 50927755 ↗
• 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 ↗
• MalfunctionJan 15, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING SWIFTPAC COILS (SWIFTPAC) AND A MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EMBOLIZED THE TARGET VESSEL WITH GLUE. WHILE ADVANCING A SWIFTPAC OUT OF THE MICROCATHETER, THE PHYSICIAN WAS UNABLE TO PUSH THE SWIFTPAC FURTHER. UNDER FLUOROSCOPY, THE PHYSICIAN NOTICED THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE MICROCATHETER AND PARTIALLY IN THE TARGET VESSEL. A SNARE DEVICE WAS USED TO SUCCESSFULLY REMOVE THE EMBOLIZATION COIL FROM THE PATIENT. 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 24089921 ↗
• MalfunctionJan 6, 2026Physical Resistance/Sticking; 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 NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED EMBOLIZATION PARTICLES IN THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED A SWIFTPAC TO THE TARGET LOCATION USING THE MICROCATHETER AND DECIDED TO REPOSITION THE SWIFTPAC. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING AND RETRACTING THE SWIFTPAC. WHILE RETRACTING, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED. WHILE ADVANCING THE NEXT SWIFTPAC THROUGH THE MICROCATHETER, THE SWIFTPAC PUSHER ASSEMBLY KINKED. THE SWIFTPAC WAS REMOVED. 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 23981463 ↗
• InjuryJun 9, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) IN M3/M4 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING SWIFTPAC COIL (SWIFTPAC), A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA COIL IN THE TARGET VESSEL. NEXT, WHILE ADVANCING A SWIFTPAC INTO THE VESSEL, THE COIL UNINTENTIONALLY DETACHED. IT WAS REPORTED THE SWIFTPAC DETACHED MOSTLY IN THE VESSEL WITH 5 TO 10CM IN THE MCA. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO REPOSITION THE END SEGMENT OF SWIFTPAC FROM THE MCA INTO THE M3/M4 USING THE COILS PUSHER WIRE, A GUIDEWIRE, AND MICROCATHETER, BUT THE ATTEMPTS WERE NOT SUCCESSFUL. THEREFORE, THE SWIFTPAC LEFT IN PLACE. THE PROCEDURE WAS ABORTED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22172202 ↗
• MalfunctionJun 6, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE MENINGEAL ARTERY (MMA) USING A SWIFTPAC COIL (SWIFTPAC), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE MAJORITY OF THE SWIFTPAC INTO THE TARGET LOCATION. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO REMOVE THE SWIFTPAC FOR A SHORTER COIL. WHILE RETRACTING THE SWIFTPAC PUSHER ASSEMBLY, THE SWIFTPAC DID NOT RETRACT. THE SWIFTPAC HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. AFTER REMOVING THE SWIFTPAC PUSHER ASSEMBLY, THE PHYSICIAN USED A 3CC SYRINGE TO PUSH THE DETACHED SWIFTPAC OUT OF THE MICROCATHETER AND INTO THE RIGHT INTERNAL MAXILLARY ARTERY (IMAX). THE PHYSICIAN DEEMED IT WAS SAFE TO LEAVE THE DETACHED SWIFTPAC IN THE IMAX. THE PROCEDURE WAS COMPLETED AT THIS POINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22158778 ↗
• InjuryMay 16, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING A SWIFTPAC COIL (SWIFTPAC), NON-PENUMBRA COILS, AND A FLOW DIVERTER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS AND NINE SWIFTPAC COILS IN THE TARGET LOCATION. A FLOW DIVERTER WAS THEN PLACED IN THE VESSEL. NEXT, AFTER ADVANCING APPROXIMATELY TWENTY CENTIMETERS OF A SWIFTPAC COIL IN THE VESSEL, THE PHYSICIAN NOTICED THE SWIFTPAC COIL STARTED TO RUN BEHIND THE FLOW DIVERTER. THE PHYSICIAN ATTEMPTED TO RETRACT THE SWIFTPAC COIL, BUT EXPERIENCED RESISTANCE AND THE SWIFTPAC COIL UNINTENTIONALLY DETACHED IN THE VESSEL. IT WAS REPORTED THAT TWO STENTS WERE PLACED TO PIN THE SWIFTPAC COIL AGAINST THE VESSEL WALL. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22035439 ↗