Smart Coil 400SMTSTD0615Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00814548014661), received between Feb 12, 2016 and Aug 27, 2020 — classified as 2 injuries, 5 malfunctions.

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A PENUMBRA SMART COIL (SMART COIL) AND A MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE SMART COIL THROUGH THE MICROCATHETER, THE SMART COIL KINKED; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10459744 ↗
• MalfunctionSep 3, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, WHILE ADVANCING THE SMART COIL ABOUT 50 CM INTO A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8957971 ↗
• InjuryDec 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE ON (B)(6) 2017 USING PENUMBRA SMART COILS (SMART COILS). AFTER THE SMART COILS WERE SUCCESSFULLY PLACED, THE HOSPITAL STAFF NOTICED A SMALL THROMBUS FORMED WITHIN THE P1 SEGMENT OF THE POSTERIOR CEREBRAL ARTERY (PCA). THE THROMBUS WAS NOT FLOW LIMITING, AND THE PHYSICIAN TREATED IT WITH A HALF BOLUS OF INTEGRILIN, HOWEVER AFTER 10-15 MINUTES THE THROMBUS WAS STILL PRESENT. ANOTHER HALF BOLUS OF INTEGRILIN WAS ADMINISTERED, BUT WAS STILL INEFFECTIVE AT TREATING THE THROMBUS, AND THEREFORE THE DECISION WAS MADE TO ASPIRATE THE THROMBUS. THE PHYSICIAN USED A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) AND A BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK) TO ATTEMPT TO REMOVE THE THROMBUS FROM THE P1 SEGMENT, HOWEVER THE PHYSICIAN WAS UNABLE TO REMOVE THE THROMBUS, AND THE OCCLUSION BECAME WORSE. THERE WAS STILL GOOD DISTAL FLOW THROUGH POSTERIOR COMMUNICATING ARTERY FROM THE ANTERIOR CIRCULATION. A SMALL DISSECTION IN THE MID-BASILAR ARTERY WAS THEN FOUND, WHICH WAS ALSO NOT FLOW LIMITING, AND WHICH WAS NOT RELATED TO THE SMART COIL SYSTEM. THE PATIENT WAS THEREFORE TREATED USING AN INTEGRILIN DRIP AND ASPIRIN WITHOUT STENT

  Patient problems: Thrombus

  MAUDE report 7076337 ↗
• MalfunctionMar 15, 2017Kinked; Failure to Advance; Physical Resistance; Kinked; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER¿S GUIDING SHEATH, CATHETER AND MICROCATHETER IN THE TARGET VESSEL. THE PHYSICIAN THEN CONNECTED A SMART COIL INTRODUCER SHEATH TO THE HUB OF THE MICROCATHETER AND ATTEMPTED TO ADVANCE THE SMART COIL; HOWEVER, RESISTANCE WAS EXPERIENCED AND THE SMART COIL WOULD NOT ADVANCE INTO THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE SMART COIL INTRODUCER SHEATH FROM THE HUB OF THE MICROCATHETER AND ATTEMPTED TO ADVANCE THE SMART COIL OUT OF ITS INTRODUCER SHEATH. HOWEVER, RESISTANCE WAS EXPERIENCED WHILE ADVANCING THE SMART COIL OUTSIDE OF THE INTRODUCER SHEATH. NEXT, THE PHYSICIAN RE-CONNECTED THE SMART COIL INTRODUCER SHEATH TO THE HUB OF THE MICROCATHETER THEN RE-ATTEMPTED TO ADVANCE THE SMART COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND SUBSEQUENTLY THE SMART COIL PUSHER ASSEMBLY BECAME KINKED. THEREFORE, IT WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER¿S COILS AND AN ADDITIONAL SMART COIL. IT SHOULD BE NOTED THAT THE PHYSICIAN DID NOT USE A ROTATING HEMOSTASIS V

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6408242 ↗
• InjuryMar 13, 2017Material Protrusion/Extrusion; Unintended Movement; Material Protrusion/Extrusion; Unintended Movement

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BASILAR TIP ANEURYSM USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, AFTER THE THIRD SMART COIL WAS DEPLOYED AND DETACHED, THE ANGIOGRAPHY SHOWED A PROTRUSION OF A PREVIOUSLY PLACED COIL. THE PHYSICIAN CONTINUED THE PROCEDURE BY PLACING SIX ADDITIONAL SMART COILS. TOWARDS THE END OF THE PROCEDURE, CLOT FORMATION WAS IDENTIFIED ON THE DISPLACED LOOP OF COIL AND AN INTEGRILIN DRIP WAS STARTED. THE PHYSICIAN THEN DECIDED TO PLACE A STENT IN ORDER TO TACK THE PROTRUDING COIL AGAINST THE WALL OF THE VESSEL. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2017. THE REPORTED CLOT FORMATION WAS ADJUDICATED TO HAVE NO RELATIONSHIP TO THE PENUMBRA DEVICES. HOWEVER, THE REPORTED COIL PROTRUSION WAS POSSIBLY RELATED TO THE ANEURYSM, PROCEDURE AND PENUMBRA SMART COILS. IT IS UNKNOWN WHICH OF THE THREE PREVIOUSLY PLACED SMART COILS PROTRUDED OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6401544 ↗
• MalfunctionMar 8, 2017Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED ANOTHER MANUFACTURER¿S MICROCATHETER AND AN INTRACRANIAL STENT DEVICE TO COVER THE NECK OF CAVERNOUS ANEURYSM IN THE TARGET VESSEL, AND THEN INITIATED THE COIL EMBOLIZATION USING A JAILING TECHNIQUE. WHILE ATTEMPTING TO ADVANCE A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN HAD DIFFICULTY RIGHT BEFORE THE COIL PUSHER ASSEMBLY WAS INSIDE THE MICROCATHETER. ALTHOUGH THE SMART COIL INTRODUCER SHEATH WAS REMOVED FROM THE PROXIMAL PORTION OF THE PUSHER ASSEMBLY, THE PHYSICIAN STILL EXPERIENCED DIFFICULTY ADVANCING THE SMART COIL. HOWEVER, THE PHYSICIAN EVENTUALLY ADVANCED THE SMART COIL INTO THE MICROCATHETER BUT THE SMART COIL WAS REMOVED BECAUSE IT SMALL. THE PHYSICIAN THEN OPENED A NEW SMART COIL. ALTHOUGH THE PHYSICIAN NOTED THAT IT WAS ALSO DIFFICULT TO ADVANCE THE NEW SMART COIL THROUGH THE MICROCATHETER LIKE THE PREVIOUS SMART COIL; THE PHYSICIAN WAS ABLE TO ADVANCE AND IMPLANT IT INTO THE ANEURYSM. THE PHYSICIAN THEN SUCCESSFULLY RE-ADVANCED AND IMPLANTED THE FIRST SMART COIL THAT WAS REMOVED DUE TO THE SIZING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6387967 ↗
• MalfunctionFeb 12, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ATTEMPTING TO ADVANCE A SMART COIL OUT OF ITS INTRODUCER SHEATH AND INTO ANOTHER MANUFACTURER'S MICROCATHETER, IT BECAME STUCK AT THE COIL AND PUSHER ASSEMBLY JUNCTION AND WAS UNABLE TO BE ADVANCED ANY FURTHER. IT WAS REPORTED THAT NO RESISTANCE WAS FELT WHILE ADVANCING THE SMART COIL. THE PHYSICIAN REMOVED THE SMART COIL FROM THE PATIENT AND COMPLETED THE PROCEDURE USING A NEW SMART COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5434094 ↗