Penumbra Coil 400 4006C0204Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M4244006C02040), received between Dec 29, 2015 and Apr 25, 2019 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE MAJOR AORTOPULMONARY COLLATERAL ARTERY (MAPCA) USING PENUMBRA COIL 400S (PC400). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED SMART COILS IN THE COLLATERAL CIRCULATION USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING A NEW PC400, THE PHYSICIAN EXPERIENCED RESISTANCE APPROXIMATELY 20 CENTIMETERS INTO THE MICROCATHETER AND, THEREFORE, THE COIL WAS RETRACTED. WHILE RETRACTING THE PC400, IT UNINTENTIONALLY DETACHED AT THE HUB OF THE MICROCATHETER. THEREFORE, THE LANTERN WAS REMOVED CONTAINING THE DETACHED PC400. THE PROCEDURE WAS COMPLETED USING NEW PC400¿S WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8549048 ↗
• MalfunctionJan 16, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING THE PC400 APPROXIMATELY THREE CENTIMETERS INTO THE INTRODUCER SHEATH; THEREFORE, THE PC400 WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO INSERT THE SAME PC400 WITHOUT USING THE ROTATING HEMOSTASIS VALVE (RHV); HOWEVER, EXPERIENCED RESISTANCE IN THE SAME AREA. THEREFORE, THE PC400 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400 WITH THE SAME LANTERN DELIVERY MICROCATHETER (LANTERN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8255493 ↗
• MalfunctionAug 22, 2017Failure to Advance; Physical Resistance; Difficult to Advance; Failure to Advance; Physical Resistance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400'S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED PC400S USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN FELT RESISTANCE ADVANCING A PC400 THROUGH ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER, AND WAS UNABLE TO ADVANCE THE PC400 THROUGH THE PX SLIM; THEREFORE, THE PC400 WAS REMOVED. IT WAS NOTICED THAT THE PX SLIM WAS KINKED NEAR THE STRAIN RELIEF ON THE PROXIMAL END OF THE CATHETER; THEREFORE, THE PX SLIM WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND A NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6810487 ↗
• InjuryApr 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400). DURING THE PROCEDURE, AFTER DELIVERING FOUR PC400 COILS IN THE TARGET VESSEL, IT WAS NOTICED THAT A PC400 LOOP WAS PROLAPSING IN THE ANTERIOR COMMUNICATING ARTERY (ACOM). NO FLOW OR THROMBOEMBOLIC PROBLEMS WERE OBSERVED; HOWEVER, THE PROTRUDING PC400 LOOP WAS SECURED USING A STENT AND DUAL ANTIPLATELET THERAPY (DAPT). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6498920 ↗
• MalfunctionAug 3, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COILS 400 (PC400) WITH A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE RETRACTING A PC400 THROUGH THE PX SLIM, THE PC400 UNINTENTIONALLY DETACHED AND, THEREFORE, WAS REMOVED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5842853 ↗
• InjuryDec 29, 2015Difficult or Delayed Positioning; Migration or Expulsion of Device; Unintended Movement

  THE FOLLOWING IS BASED ON A LITERATURE REVIEW OF AN ARTICLE ENTITLED: A CASE OF MULTIPLE UNRUPTURED CEREBRAL ANEURYSM ASSOCIATED WITH PERSISTENT PRIMITIVE HYPOGLOSSAL ARTERY, WHICH WAS PUBLISHED IN THE JOURNAL OF NEUROENDOVASCULAR THERAPY ON SEPTEMBER 03, 2015: ON (B)(6) 2012, THE PATIENT WAS UNDERGOING A BALLOON-ASSISTED COIL EMBOLIZATION IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN PLACED ANOTHER MANUFACTURER'S BALLOON CATHETER IN THE NECK OF THE ANEURYSM AND THEN DELIVERED TWENTY-SEVEN PC400 COILS INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). AN ANGIOGRAPHY WAS PERFORMED, WHICH REVEALED THAT PART OF THE TWENTY-SEVENTH PC400 COIL WAS FLOATING AND PROTRUDING OUT FROM THE ANEURYSM INTO THE RIGHT ICA. THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S MICROCATHETER INTO THE RIGHT MIDDLE CEREBRAL ARTERY AND THEN PLACED A STENT IN ORDER TO PRESS THE FLOATING PC400 COIL ONTO THE TARGET BLOOD VESSEL SO THAT THE STENT CAN COVER THE NECK OF THE ANEURYSM. THE FINAL ANGIOGRAPHY REVEALED NO ABNORMALITIES IN THE CEREBRAL ARTERIES AND THE PATIENT WAS DISCHARGED ONE WEEK AFTER THE PROCEDURE. THERE WA

  Patient problems: Foreign Body In Patient

  MAUDE report 5333824 ↗