Swift Coil System 400SWPC15-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815948029552), received between Sep 6, 2024 and Feb 20, 2026 — 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.

• 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 ↗
• MalfunctionJun 13, 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 PHYSICIAN BEGAN ADVANCING A SWIFTPAC COIL INTO THE TARGET SITE. WHILE REPOSITIONING THE COIL, THE SWIFTPAC COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE MICROCATHETER AND MOSTLY IN THE TARGET VESSEL. THE PHYSICIAN USED SALINE TO PUSH THE REST OF THE SWIFTPAC COIL INTO THE TARGET VESSEL. 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 22205991 ↗
• MalfunctionSep 6, 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), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE SWIFTPAC THROUGH THE MICROCATHETER AND INTO THE TARGET VESSEL. THE PHYSICIAN THEN ATTEMPTED TO REPOSITION THE SWIFTPAC. WHILE RETRACTING THE SWIFTPAC FOR BETTER POSITIONING, THE SWIFTPAC UNINTENTIONALLY DETACHED AT THE DISTAL END OF THE MICROCATHETER. THE PHYSICIAN USED THE SWIFTPAC PUSHER ASSEMBLY TO PUSH THE DETACHED SWIFTPAC INTO THE TARGET 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 20163122 ↗