Penumbra Coil 400 4002C1235Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M4244002C12350), received between Nov 6, 2015 and Nov 2, 2021 — classified as 1 injury, 3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionNov 2, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL 400S (PC400S). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A PC400 INTO THE PX SLIM, THE PC400 BECAME STUCK. THEREFORE, THE PC400 WAS REMOVED. NEXT, WHILE ADVANCING A NEW PC400 INTO THE PX SLIM, THE SAME ISSUE OCCURRED, THE PC400 BECAME STUCK. THEREFORE, THE PC400 AND THE PX SLIM WERE REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PC400S AND A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12741068 ↗
• MalfunctionDec 19, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, A PC400 WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8179419 ↗
• InjuryNov 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE LEFT INTERNAL CAROTID ARTERY (ICA) PROCEDURE USING PENUMBRA COIL 400S (PC400). DURING THE PROCEDURE, WHILE ADVANCING THE 28TH PC400 THROUGH THE PX SLIM DELIVERY CATHETER (PX SLIM) THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PC400 UNINTENTIONALLY DETACHED WITHIN THE PX SLIM. THE PHYSICIAN THEN REMOVED THE PX SLIM IN ORDER TO REMOVE THE DETACHED PC400. THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM AND A NEW PC400. AFTER THE PROCEDURE, THE PATIENT¿S CONDITION WORSENED AND A COMPUTERIZED TOMOGRAPHY (CT) CONFIRMED THAT THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE (SAH) WHICH WAS BELIEVED TO BE FROM THE ANEURYSM. IT IS UNKNOWN WHAT CAUSED THIS SAH. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO EMBOLIZE THE PARENT VESSEL USING NON-PENUMBRA COILS IN ORDER TO TREAT THIS SAH; THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT¿S CONDITION WAS STABILIZED.

  Patient problems: Hemorrhage, Subarachnoid

  MAUDE report 6130455 ↗
• MalfunctionNov 6, 2015Positioning Failure; Device Operational Issue

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PC400 COIL FAILED TO "DEPLOY" AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING NEW PC400 COILS AND ANOTHER MANUFACTURER'S COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5208883 ↗