Smart Coil 400SMTSTD0820Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00814548014517), received between May 12, 2016 and Oct 18, 2021 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

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

• MalfunctionOct 18, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COIL). DURING THE PROCEDURE, IT WAS REPORTED THAT THE SMART COIL DID NOT DEPLOY. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12648583 ↗
• MalfunctionJun 7, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING THE SMART COIL OUT OF THE INTRODUCER SHEATH AND INTO THE MICROCATHETER. THEREFORE, THE SMART COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SMART COILS, 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

  MAUDE report 11953414 ↗
• 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 7076332 ↗
• 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 7076313 ↗
• MalfunctionMay 12, 2016Detachment Of Device Component; Retraction Problem; Detachment Of Device Component; Retraction Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA SMART COILS (SMART COILS). DURING THE PROCEDURE, WHILE ATTEMPTING TO RESHEATH THE SMART COIL, THE PHYSICIAN WAS UNABLE TO RETRACT THE COIL COMPLETELY BACK INTO ITS INTRODUCER SHEATH AND SUBSEQUENTLY, THE SMART COIL UNINTENTIONALLY DETACHED WITHIN THE OTHER MANUFACTURER'S MICROCATHETER. THE DETACHED SMART COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING NEW 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 5651951 ↗