Smart Coil 400SMTXSFT4H12Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00814548017204), received between Jun 23, 2017 and Jan 13, 2023 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING A PENUMBRA SMART COIL (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, IT WAS NOTED UNDER FLUOROSCOPY THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED SMART COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158167 ↗
• MalfunctionJan 27, 2022Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RT CAVERNOUS SINUS USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, A SMART COIL COULD NOT BE DETACHED USING THE HANDLE. THEN, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE SMART COIL BY BREAKING THE PUSHER ASSEMBLY; HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE SMART COIL. WHILE RETRACTING THE SMART COIL, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. SALINE WAS THEN USED TO PUSH THE SMART COIL TO THE TARGET LOCATION. THE SAME ISSUE OCCURRED WITH ADDITIONAL THREE SMART COILS. ALL THREE DETACHED SMART COILS WERE IMPLANTED IN THE CAVERNOUS SINUS BY USING SALINE. THE PROCEDURE WAS COMPLETED USING THIRTY-ONE NON-PENUMBRA COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367465 ↗
• MalfunctionDec 8, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR CEREBRAL ARTERIES (PCA) USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE SMART COIL WOULD NOT ADVANCE FROM THE STARTING POSITION WITHIN ITS INTRODUCER SHEATH, AND SUBSEQUENTLY THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE SMART COIL. THEREFORE, THE SMART COIL WAS REMOVED. 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 12960519 ↗
• MalfunctionDec 7, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL TO TRANSVERSE SINUS FISTULA USING PENUMBRA SMART COILS (SMART COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE SMART COIL WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE SMART COIL WAS REMOVED. 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 12957889 ↗
• MalfunctionJul 17, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE TRANSVERSE SINUS USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A SMART COIL INTO THE HUB OF THE MICROCATHETER. IT WAS ALSO REPORTED THAT THE SMART COIL WAS PUSHED THROUGH AGAINST THE RESISTANCE AND, CONSEQUENTLY, THE SMART COIL PUSHER ASSEMBLY KINKED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW SMART 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 10287436 ↗
• MalfunctionFeb 18, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL INTO THE ANEURYSM USING THE MICROCATHETER, IT WAS REPORTED THAT THE LAST REMAINING FIVE CENTIMETERS OF THE SMART COIL KEPT KICKING OUT THE MICROCATHETER AND, THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL OF THE SAME SIZE 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 9722725 ↗
• 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 7076312 ↗
• MalfunctionOct 30, 2017Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A SMART COIL INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN DETERMINED THAT THE COIL WAS TOO BIG FOR THE ANEURYSM AND DECIDED TO PULL IT BACK; HOWEVER, WHILE RETRACTING THE SMART COIL, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. WITHOUT REALIZING THAT THE SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW SMART COIL THROUGH THE MICROCATHETER. HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PHYSICIAN REALIZED THAT THE PREVIOUS SMART COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER; THEREFORE, THE NEW SMART COIL WAS REMOVED INTACT. THE MICROCATHETER CONTAINING THE DETACHED COIL WAS THEN REMOVED AND THE COIL WAS FLUSHED OUT. AFTER THAT, THE MICROCATHETER WAS REINSERTED INTO THE PATIENT¿S BODY. THE PHYSICIAN THEN DETERMINED THAT THE SMART COIL THAT WAS PREVIOUSLY REMOVED INTACT WAS THE WRONG SIZE PRIOR TO REINSERTING IT INTO THE MICROCATHETER AND CONTINUED T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6988737 ↗
• InjuryJun 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY USING EIGHT PENUMBRA SMART COILS (SMART COILS) WITH NO COMPLICATIONS. LATER THAT DAY, THE PATIENT WAS FOUND TO HAVE TRANSIENT EYE FLOATERS IN THE LEFT EYE OF MODERATE SEVERITY. A COMPUTED TOMOGRAPHY (CT) WAS TAKEN AND WAS NEGATIVE FOR STROKE. THE PHYSICIAN SUSPECTED THAT THE EYE FLOATERS MAY HAVE BEEN TRANSIENT DUE TO THE LARGER AMOUNT OF CONTRAST ADMINISTERED DURING THE PROCEDURE THAN NORMAL. NO OTHER ACTION WAS TAKEN TO TREAT THIS EVENT. ON (B)(6) 2017, THE PATIENT EXPERIENCED NEUROLOGICAL DECLINE OF RIGHT-SIDED WEAKNESS, RESULTING IN PROLONGED HOSPITALIZATION. A CT ANGIOGRAPHY WAS TAKEN, WHICH SHOWED SCATTERED PUNCTUATED INFARCTS THROUGHOUT THE BILATERAL FRONTAL AND PARIETAL LOBES SUGGESTIVE OF EMBOLIC DISEASE. NO ACTION WAS TAKEN TO TREAT THIS EVENT. THE PATIENT WAS DISCHARGED THE NEXT DAY ON (B)(6) 2017. THE REPORTED TRANSIENT EYE FLOATERS WAS ADJUDICATED BY THE PHYSICIAN TO BE POSSIBLY RELATED TO THE DISEASE STATE, PROCEDURE, AND THE SMART COIL SYSTEM. THE REPORTED NEUROLOGICAL DECLINE WAS ADJUDICATED BY THE PHYSICIAN TO BE UNRELATED TO THE DISEASE STATE, POSSIBLY RELATED

  Patient problems: Infarction, Cerebral; Vitreous Floaters; Weakness

  MAUDE report 6664865 ↗