Smart Coil 400SMTSTD1360Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814548014265), received between Dec 29, 2017 and Sep 21, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MAXILLARY ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THREE SMART COILS WERE UNABLE TO ADVANCE AT ALL FROM THEIR INITIAL POSITION WITHIN THEIR RESPECTIVE INTRODUCER SHEATHS. THEREFORE, THE THREE SMART COILS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509559 ↗
• MalfunctionJul 30, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THREE SMART COILS WOULD NOT ADVANCE FROM THE STARTING POSITION OF THEIR INTRODUCER SHEATHS DUE TO THE FRICTION LOCKS BEING TOO TIGHT. THE PROCEDURE WAS COMPLETED USING A NEW SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252786 ↗
• MalfunctionMay 25, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE PAST ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11879442 ↗
• MalfunctionApr 22, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR ANEURYSM USING PENUMBRA SMART COILS (SMART COIL), PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), NON-PENUMBRA COILS, NON-PENUMBRA SHEATH, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN FIRST PLACED OTHER COILS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ATTEMPTING TO PLACE THE FIRST SMART COIL IN THE TARGET LOCATION, THE PHYSICIAN NOTICED THE SMART COIL WAS STUCK AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. SUBSEQUENTLY, TWO NEW SMART COILS WERE PLACED AND DETACHED IN THE TARGET VESSEL USING THE HANDLE. WHILE ATTEMPTING TO PLACE ANOTHER SMART COIL, THE SAME ISSUE OCCURRED, AND THE SMART COIL WAS STUCK AND WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. THEREFORE, IT WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED ANOTHER SMART COIL IN THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. AN ATTEMPT WAS MADE TO MANUALLY DETACH THE PUSHER ASSEMBLY OF THE SMART COIL, BUT THE COIL STILL FAILED TO DETACH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. HOWEVER, WHILE RETRACTING, THE S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710305 ↗
• MalfunctionDec 29, 2017Detachment Of Device Component; Premature Activation; Physical Resistance; Detachment Of Device Component; Premature Activation; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CAVERNOUS SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A SMART COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE COIL; HOWEVER, UPON RETRACTION, THE SMART COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED THE SMART COIL PUSHER ASSEMBLY TO PUSH THE DETACHED COIL OUT OF THE MICROCATHETER AND INTO THE ANEURYSM. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7154731 ↗