Penumbra Coil 400 4002C2260Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M4244002C22600), received between Oct 30, 2015 and Sep 24, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 18, 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.

• MalfunctionSep 24, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM IN A COLLATERAL SEGMENT VESSEL CONNECTING RENAL, SPLENIC, AND PORTAL VEINS USING PENUMBRA COIL 400S (PC400S), NON-PENUMBRA COILS, NON-PENUMBRA VASCULAR PLUG, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA DIAGNOSTIC CATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO PC400S DISTAL TO THE ANEURYSM USING THE MICROCATHETER. IT WAS REPORTED THAT A VASCULAR PLUG WAS PLACED BUT NOT DETACHED. THEN, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS PROXIMAL TO THE ANEURYSM. AFTERWARDS, WHILE THE PHYSICIAN ADVANCED ANOTHER PC400 THROUGH THE MICROCATHETER DISTAL TO THE ANEURYSM, THE PC400 UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. IT WAS REPORTED THAT THE PROXIMAL END OF THE PC400 WAS INSIDE THE MICROCATHETER AND THE DISTAL END OF THE PC400 WAS INSIDE THE VESSEL. SUBSEQUENTLY, THE DETACHED PC400 WAS REMOVED WITH DIFFICULTY USING A PUSHER WIRE OF A VASCULAR PLUG AND THE MICROCATHETER WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED BY PLACING A VASCULAR PLUG. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530551 ↗
• MalfunctionOct 3, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, WHILE ADVANCING THE PC400 THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PC400 BECAME STUCK. THE PHYSICIAN THEN FLUSHED THE MICROCATHETER AND ATTEMPTED TO ADVANCE THE PC400 AGAIN; HOWEVER, THE PC400 WOULD NOT ADVANCE ANY FURTHER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PC400; HOWEVER, DURING RETRACTION, THE PC400 UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PC400 WAS REMOVED, AND THE PC400 WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING OTHER PC400S 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 9151487 ↗
• MalfunctionJun 10, 2019Break; Stretched; Physical Resistance/Sticking; Break; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THIRTEEN COILS USING THE LANTERN. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A PC400 IN THE LANTERN AND FOUND THAT THE RESISTANCE WAS INCREASING WHILE THE PC400 WAS ADVANCED AND RETRACTED WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN WITH THE PC400 INSIDE. IT WAS REPORTED THAT THE PC400 THEN BECAME STRETCHED AND BROKE WITHIN THE MICROCATHETER AND, THEREFORE, THE PHYSICIAN CUT THE PC400 AND FLUSHED THE LANTERN TO REMOVE THE REST OF THE COIL. THE PROCEDURE WAS THEN COMPLETED USING A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8683653 ↗
• MalfunctionMay 22, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE FIRST PC400 IN THE MIDDLE OF THE LANTERN; THEREFORE, THE PC400 WAS REMOVED. WHILE ADVANCING THE SECOND PC400 THE SAME ISSUE OCCURRED AND THE COIL AND THE LANTERN WERE REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE LANTERN WAS KINKED AT THE SHAFT. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER MICROCATHETER AND ADDITIONAL PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633733 ↗
• MalfunctionMay 22, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE FIRST PC400 IN THE MIDDLE OF THE LANTERN; THEREFORE, THE PC400 WAS REMOVED. WHILE ADVANCING THE SECOND PC400 THE SAME ISSUE OCCURRED AND THE COIL AND THE LANTERN WERE REMOVED. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE LANTERN WAS KINKED AT THE SHAFT. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER MICROCATHETER AND ADDITIONAL PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633728 ↗
• MalfunctionNov 16, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND THE PC400 COIL WAS UNABLE TO ADVANCE. THEREFORE THE PHYSICIAN RETRACTED THE PC400 THEN FLUSHED THE PX SLIM BEFORE ATTEMPTING TO ADVANCE THE SAME PC400 COIL AGAIN. HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN WHILE ADVANCING THE PC400 COIL THROUGH THE PX SLIM; THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME PX SLIM AND A NEW PC400. THE PHYSICIAN REPORTED THAT CONTINUOUS FLUSH WAS MAINTAINED AND A ROTATING HEMOSTASIS VALVE WAS USED. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6106640 ↗
• MalfunctionOct 30, 2015Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ILIAC ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DELIVERED FIVE RUBY COILS INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). WHILE DEPLOYING A PC400 COIL INTO THE ANEURYSM, THE PHYSICIAN ATTEMPTED TO REPOSITION THE COIL BY PULLING IT BACK INTO ITS ORANGE SHEATH THROUGH THE PX SLIM. HOWEVER, THE PC400 COIL UNINTENTIONALLY DETACHED INSIDE ITS ORANGE SHEATH AND WAS REMOVED. THE PROCEDURE CONTINUED USING A NEW PC400 COIL AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5190455 ↗