Penumbra Coil 400 4006U0201Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M4244006U02010), received between Feb 24, 2016 and Oct 18, 2016 — classified as 3 injuries, 2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2016Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OPHTHALMIC ARTERY USING PENUMBRA COIL 400S (PC400). DURING THE PROCEDURE, THE PHYSICIAN FIRST PLACED A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX) AND ADVANCED A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PC400 IN THE ANEURYSM. AFTER ADVANCING THE THIRD PC400 THROUGH THE PX SLIM, THE PHYSICIAN ATTEMPTED TO RETRACT THE PC400 IN ORDER TO REPOSITION IT. HOWEVER, WHILE RETRACTING THE PC400, IT UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY IN THE PATIENT'S BODY AND OCCLUDED THE M3 SEGMENT OF THE MIDDLE CEREBRAL ARTERY. THE PHYSICIAN USED A SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE DETACHED COIL. THE PROCEDURE WAS ENDED AT THIS POINT AND THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. IT SHOULD BE NOTED THAT THE PHYSICIAN USED A ROTATING HEMOSTASIS VALVE (RHV) AND MAINTAINED CONTINUOUS FLUSH THROUGHOUT THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 6038539 ↗
• MalfunctionMay 9, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED AN INITIAL PC400 COIL INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN ATTEMPTED TO ADVANCE TWO NEW PC400 COILS THROUGH THE PX SLIM; HOWEVER, BOTH COILS WOULD NOT ADVANCE INTO THE PX SLIM AND WERE REMOVED. AFTER THE TWO FAILED ATTEMPTS, THE PHYSICIAN DECIDED TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5641768 ↗
• MalfunctionMay 9, 2016Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED AN INITIAL PC400 COIL INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THE PHYSICIAN THEN ATTEMPTED TO ADVANCE TWO NEW PC400 COILS THROUGH THE PX SLIM; HOWEVER, BOTH COILS WOULD NOT ADVANCE INTO THE PX SLIM AND WERE REMOVED. AFTER THE TWO FAILED ATTEMPTS, THE PHYSICIAN DECIDED TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5641717 ↗
• InjuryFeb 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SUCCESSFULLY UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COILS 400 (PC400 COILS). SIX MONTHS POST-PROCEDURE THE PATIENT EXPERIENCED TRANSIENT NEUROLOGIC DEFICIT AND WAS TREATED WITH PLAVIX. A MAGNETIC RESONANCE IMAGING/ANGIOGRAPHY (MRI/MRA) CONFIRMED THAT THIS SERIOUS ADVERSE EFFECT (TRANSIENT NEUROLOGIC DEFICIT) WAS RESOLVED. THIS SERIOUS ADVERSE EFFECT WAS ADJUDICATED TO HAVE AN UNCERTAIN RELATIONSHIP TO THE PC400 COILS, AND AN UNRELATED RELATIONSHIP TO BOTH THE ANGIOGRAPHIC PROCEDURE AND THE ANEURYSM/MALFORMATION DISEASE STATE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 5459199 ↗
• InjuryFeb 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SUCCESSFULLY UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING PENUMBRA COILS 400 (PC400 COILS). SIX MONTHS POST-PROCEDURE THE PATIENT EXPERIENCED TRANSIENT NEUROLOGIC DEFICIT AND WAS TREATED WITH PLAVIX. A MAGNETIC RESONANCE IMAGING/ANGIOGRAPHY (MRI/MRA) CONFIRMED THAT THIS SERIOUS ADVERSE EFFECT (TRANSIENT NEUROLOGIC DEFICIT) WAS RESOLVED. THIS SERIOUS ADVERSE EFFECT WAS ADJUDICATED TO HAVE AN UNCERTAIN RELATIONSHIP TO THE PC400 COILS, AND AN UNRELATED RELATIONSHIP TO BOTH THE ANGIOGRAPHIC PROCEDURE AND THE ANEURYSM/MALFORMATION DISEASE STATE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 5458680 ↗