Smart Coil 400SMTSTD0515Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00814548014647), received between Aug 20, 2015 and Aug 18, 2021 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID CAVERNOUS FISTULA (CCF) USING PENUMBRA SMART COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN REALIZED THAT THE COIL CHOSEN WAS TOO BIG FOR THE TARGET VESSEL AND THEREFORE, DECIDED TO RE-SHEATH THE SMART COIL. WHILE RE-SHEATHING THE SMART COIL, THE PHYSICIAN KNOTTED THE SMART COIL. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL OF A SMALLER SIZE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340232 ↗
• MalfunctionMar 4, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH AFTER MULTIPLE ATTEMPTS WERE MADE. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11416925 ↗
• MalfunctionFeb 2, 2021Break; Failure to Advance; Break; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A SMART COIL IN THE ANEURYSM; HOWEVER, THE PHYSICIAN WAS UNABLE TO PLACE THE SMART COIL COMPLETELY IN THE ANEURYSM AND DECIDED TO REMOVE THE SMART COIL. UPON RETRACTION, ONLY PART OF THE SMART COIL WAS REMOVED, AND THE OTHER PART OF THE SMART COIL GOT CAUGHT IN THE STENT AND BROKE OFF. IT WAS REPORTED THAT THE PART OF THE SMART COIL THAT BROKE OFF REMAINS SECURELY IN PLACE IN THE PATIENT¿S VESSEL. IT WAS ALSO REPORTED THAT THE PHYSICIAN DID NOT EXPERIENCE ANY SIGNIFICANT RESISTANCE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11267920 ↗
• MalfunctionJun 12, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA SMART COILS (SMART COILS) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A SMART COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE SMART COIL WOULD NOT ADVANCE. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS 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 10149020 ↗
• MalfunctionMar 19, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPINAL ARTERY USING A PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE SMART COIL WOULD NOT ADVANCE AT ALL WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857213 ↗
• MalfunctionSep 4, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS (F88573 AND F84429) WOULD NOT ADVANCE WITHIN THEIR INTRODUCER SHEATHS, AND ONE SMART COIL (F87328) WOULD NOT ADVANCE THROUGH THE NON-PENUMBRA MICROCATHETER; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER SMART COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8962975 ↗
• MalfunctionJul 17, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE PANCREATIC ARTERY USING A PENUMBRA SMART COIL (SMART COIL). DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED A NON-PENUMBRA MICROCATHETER IN THE TARGET VESSEL AND WHILE ATTEMPTING TO ADVANCE THE FIRST SMART COIL IN THE INTRODUCER SHEATH, RESISTANCE WAS EXPERIENCED. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY PLACING EIGHT ADDITIONAL SMART COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8798832 ↗
• MalfunctionDec 6, 2017Difficult to Remove; Retraction Problem; Mechanical Jam; Difficult to Remove; Retraction Problem; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR CHOROIDAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, AFTER ADVANCING A SMART COIL IN THE ANEURYSM USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN DETERMINED THAT THE SMART COIL WAS THE INCORRECT SIZE AND DECIDED TO WITHDRAW IT; HOWEVER, WHILE ATTEMPTING TO WITHDRAW THE SMART COIL FROM THE ANEURYSM, THE SMART COIL BECAME STUCK INSIDE THE NON-PENUMBRA MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE SMART COIL ALTOGETHER. THE PROCEDURE WAS COMPLETED USING ANOTHER SMART COIL AND ANOTHER NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7087585 ↗
• 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 7076316 ↗
• MalfunctionJul 18, 2017Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A VESSEL SACRIFICE IN THE ANTERIOR CEREBRAL ARTERY-ANTERIOR COMMUNICATING ARTERY (ACA-ACOM) USING PENUMBRA SMART COILS (SMART COIL) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AN INITIAL SMART COIL INTO THE TARGET VESSEL AND MADE ONE ATTEMPT TO DETACH IT USING THE HANDLE BUT WAS UNSUCCESSFUL. A SECOND ATTEMPT WAS MADE TO DETACH THE COIL USING THE SAME HANDLE AND THE COIL DETACHED SUCCESSFULLY. THE PROCEDURE WAS THEN COMPLETED USING THREE ADDITIONAL SMART COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6723714 ↗
• MalfunctionJan 10, 2017Physical Resistance; Device Operates Differently Than Expected; Physical Resistance; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CEREBRAL ARTERY USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED AND DEPLOYED A SMART COIL IN THE ANEURYSM USING A NON-PENUMBRA MICROCATHETER. HOWEVER, THE SMART COIL WAS NOT WELL COMPACTED WITHIN THE ANEURYSM; THEREFORE, THE PHYSICIAN RETRACTED AND RE-ADVANCED THE SMART COIL MULTIPLE TIMES WITH NO SUCCESS. THE SMART COIL WAS THEN REMOVED AND A VASCULAR RECONSTRUCTION DEVICE (VDR) WAS PLACED. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE THE PREVIOUS SMART COIL THROUGH THE NON-PENUMBRA MICROCATHETER; HOWEVER, RESISTANCE WAS EXPERIENCED AND THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME NON-PENUMBRA MICROCATHETER AND NEW SMART COILS. THE PHYSICIAN REPORTED MAINTAINING CONTINUOUS FLUSH AND NOT USING A ROTATING HEMOSTASIS VALVE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6239380 ↗
• MalfunctionMay 31, 2016Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, TWO SMART COILS FELL ONTO THE FLOOR PRIOR TO BEING USED. THEREFORE, BOTH COILS WERE NOT USED FOR THE PROCEDURE AND DID NOT ENTER THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING NEW SMART COILS.

  Patient problems: No Patient Involvement

  MAUDE report 5690157 ↗
• MalfunctionDec 9, 2015Activation, Positioning or Separation Problem; Device Operational Issue

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE) . DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY DETACHING FIVE SMART COILS IN SEQUENCE USING THE HANDLE; HOWEVER, THE SMART COILS DETACHED AFTER MULTIPLE ATTEMPTS AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5282776 ↗
• MalfunctionAug 20, 2015Detachment Of Device Component; Retraction Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS. DURING THE PROCEDURE, THE PHYSICIAN MET RESISTANCE WHILE ATTEMPTING TO REMOVE THE SMART COIL FROM ANOTHER MANUFACTURER'S MICROCATHETER. WHILE REMOVING THE SMART COIL AGAINST RESISTANCE, IT UNINTENTIONALLY DETACHED PARTIALLY INSIDE THE MICROCATHETER AND PARTIALLY OUT OF THE HUB. THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE DETACHED SMART COIL INSIDE AND THE PROCEDURE SUCCESSFULLY CONTINUED USING A NEW CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5019509 ↗