Smart Coil 400SMTSTD0715Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00814548014487), received between Nov 21, 2016 and Feb 25, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2022Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR ANEURYSM USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL HANDLES (HANDLES), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL THROUGH THE MICROCATHETER TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL WITH A NEW SECOND HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ALSO ATTEMPTED TO MANUALLY DETACH THE SMART COIL BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NEW SMART COILS USING THE SECOND HANDLE AND THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A NEW SMART COIL THROUGH THE MICROCATHETER TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE SECOND HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL WITH A NEW THIRD HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ALSO ATTEMPTED TO MANUALLY DETACH THE SMART COIL BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN REMOVED THE PUSHER A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13604355 ↗
• MalfunctionFeb 25, 2022Difficult or Delayed Separation; Premature Separation; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR ANEURYSM USING PENUMBRA SMART COILS (SMART COILS), PENUMBRA SMART COIL HANDLES (HANDLES), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL THROUGH THE MICROCATHETER TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL WITH A NEW SECOND HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ALSO ATTEMPTED TO MANUALLY DETACH THE SMART COIL BUT WAS UNSUCCESSFUL. THEREFORE, THE SMART COIL WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NEW SMART COILS USING THE SECOND HANDLE AND THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN ADVANCED A NEW SMART COIL THROUGH THE MICROCATHETER TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE SECOND HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN ATTEMPTED TO DETACH THE SMART COIL WITH A NEW THIRD HANDLE; HOWEVER, THE SMART COIL FAILED TO DETACH. THE PHYSICIAN ALSO ATTEMPTED TO MANUALLY DETACH THE SMART COIL BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN REMOVED THE PUSHER A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13604344 ↗
• MalfunctionJun 20, 2017Device Handling Problem; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT A SUBARACHNOID HEMORRHAGE USING A PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE SCRUB TECHNOLOGIST INADVERTENTLY DROPPED THE END OF THE COIL PUSHER ASSEMBLY ONTO THE FLOOR AND THE COIL BECAME UNSTERILE. THEREFORE, THE SMART COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A TOTAL OF (B)(4) SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6654956 ↗
• MalfunctionNov 21, 2016Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT A CEREBRAL ANEURYSM USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A SMART COIL IN THE TARGET VESSEL USING ANOTHER MANUFACTURER¿S MICROCATHETER AND REALIZED THAT THE SIZE OF THE COIL DID NOT MATCH THE SIZE OF THE ANEURYSM. THEREFORE, THE SMART COIL WAS RETRACTED AND RE-SHEATHED. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER SMART COIL INTO THE TARGET VESSEL; HOWEVER, THE PHYSICIAN REALIZED THAT THE COIL SIZE DID NOT MATCH THE SIZE OF THE ANEURYSM. THEREFORE, THE SMART COIL WAS RETRACTED AND RE-SHEATHED. IT WAS REPORTED THAT THE PHYSICIAN SOAKED THE SMART COILS IN HEPARINIZED SALINE AFTER THEY WERE RETRACTED. THEREAFTER, THE PHYSICIAN DEPLOYED AND DETACHED A NEW SMART COIL AND ANOTHER MANUFACTURER¿S COIL IN THE ANEURYSM USING THE SAME MICROCATHETER. WHILE ATTEMPTING TO USE ONE OF THE PREVIOUS SMART COILS THAT WERE REMOVED FROM THE PATIENT, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WAS UNABLE TO ADVANCE OUT OF ITS INTRODUCER SHEATH. BOTH SMART COILS WERE THEN DISCARDED BEFORE BEING RETRIEVED AGAIN. HOWEVER, AFTER RETRIEVAL FROM THE GARBAGE, ONE OF THE SMART COILS WAS DETACHED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6117041 ↗