Smart Coil 400SMTSTD1560Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814548014302), received between Nov 21, 2018 and Nov 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 21, 2018Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE EXTERNAL CAROTID ARTERY (ECA) USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE SMART COIL. THE PHYSICIAN THEN CHOSE ANOTHER SMART COIL AND WAS ABLE TO ADVANCE IT A LITTLE FARTHER THAN THE PREVIOUS SMART COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND UPON REMOVAL, THE SMART COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND ADDITIONAL COILS. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8097958 ↗