Penumbra Coil 400 4006C0203Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M4244006C02030), received between Nov 11, 2015 and Nov 22, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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.

• MalfunctionNov 22, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE A1 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A PENUMBRA COIL 400 (PC400), AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PX SLIM INTO THE TARGET VESSEL USING THE NEURON MAX AND CATHETER. NEXT, WHILE ADVANCING THE PC400 THROUGH THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE PC400. UPON RETRACTION, THE PC400 UNINTENTIONALLY DETACHED AND WAS STUCK WITHIN THE PX SLIM. THEREFORE, THE PX SLIM CONTAINING THE DETACHED PC400 WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THREE NON-PENUMBRA COILS, THE SAME NEURON MAX, THE SAME CATHETER, AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15845516 ↗
• MalfunctionDec 12, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA COIL 400 (PC400'S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 OUT OF ITS INTRODUCER SHEATH AND INTO THE HUB OF A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING NEW PC400'S 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 7110385 ↗
• MalfunctionJan 18, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANTERIOR COMMUNICATING ARTERY (A-COM) ANEURYSM USING PENUMBRA COILS 400 (PC400¿S) AND A PXSLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED A PC400 IN THE A-COM USING A PX SLIM; HOWEVER, THE PC400 WAS NOT THE RIGHT SIZE AND THEREFORE WAS REMOVED AND REPLACED WITH A SMALLER PC400. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PC400 THROUGH THE SAME PX SLIM; HOWEVER, RESISTANCE WAS ENCOUNTERED WITHIN THE FIRST FEW CENTIMETERS AFTER THE INSERTION AND THE PC400 WOULD NOT ADVANCE THROUGH THE PX SLIM AND THEREFORE, IT WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO ADVANCE A MICRO-WIRE THROUGH THE PX SLIM PRIOR AND AFTER TO ATTEMPTING TO USE THE NEXT PC400; HOWEVER, THE NEW PC400 WOULD ONLY ADVANCE FEW CENTIMETERS INSIDE THE PX SLIM AND BECAME STUCK. THE PC400 AND PX SLIM WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER¿S MICROCATHETER AND COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6260662 ↗
• MalfunctionAug 4, 2016Kinked; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, WHILE ADVANCING A PC400 COIL THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN DID NOT ENCOUNTER ANY RESISTANCE; HOWEVER, THE PC400 COIL PUSHER ASSEMBLY BECAME KINKED. THEREFORE, THE PC400 COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED 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 5847929 ↗
• InjuryJul 19, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE CHOROIDAL SEGMENT OF THE RIGHT SUPRACLINOID INTERNAL CAROTID ARTERY (ICA) USING PENUMBRA COIL 400 COILS (PC400 COILS). THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS. HOWEVER, THE DAY AFTER THE PROCEDURE, THE PATIENT EXPERIENCED TWO EPISODES OF TRANSIENT LEFT-SIDED WEAKNESS. ON (B)(6) 2016, A FOLLOW-UP MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED WHICH REVEALED SMALL INFARCTS SCATTERED IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) TERRITORY, WHICH RESOLVED ON THE SAME DAY. ON (B)(6) 2016, THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY IN STABLE CONDITION. THE SMALL INFARCTS WERE REPORTED TO BE A TRANSIENT ISCHEMIC ATTACK (TIA) AND A NON-SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE PC400 COILS, THE ANEURYSM AS WELL AS THE ANGIOGRAPHIC PROCEDURE.

  Patient problems: Transient Ischemic Attack; Weakness

  MAUDE report 5804477 ↗
• MalfunctionNov 11, 2015Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, WHILE IN USE WITH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PC400 COIL WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH AND WAS REMOVED FROM THE PATIENT THROUGH THE PX SLIM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW PC400 COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5219015 ↗