Swift Coil System 400SWPC25-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815948029682), received between Jan 30, 2026 and Jan 30, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗