Swift Coil System 400SWPC20-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948029675), received between Jul 24, 2025 and Oct 30, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 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 A SWIFTPAC COIL (SWIFTPAC), 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 EXPERIENCED RESISTANCE WITH THE SWIFTPAC. THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE TARGET VESSEL AND THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED. 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 23426145 ↗
• MalfunctionAug 27, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE MENINGEAL ARTERY (MMA) USING A SWIFTPAC COIL (SWIFTPAC), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE RETRACTING THE SWIFTPAC TO REPOSITION IT, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED PARTIALLY IN THE MMA AND PARTIALLY IN THE INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN ATTEMPTED TO USE A NON-PENUMBRA STENT RETRIEVER TO REMOVE THE DETACHED EMBOLIZATION WITHOUT SUCCESS. A SECOND NON-PENUMBRA STENT RETRIEVER WAS THEN USED TO SUCCESSFULLY REMOVE THE DETACHED EMBOLIZATION COIL. THE PROCEDURE WAS COMPLETED USING EMBOLIZATION PARTICLES 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 22903397 ↗
• MalfunctionJul 24, 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, WHILE ADVANCING THE SWIFTPAC THROUGH THE MICROCATHETER TO THE TARGET LOCATION, THE SWIFTPAC UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING DETACHED SWIFTPAC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER SWIFTPAC AND ANOTHER NON-PENUMBRA MICROCATHETER (HEADWAY DUO 156CM). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592946 ↗