Penumbra Coil 400 4006C0202Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M4244006C02020), received between Oct 22, 2015 and Jan 18, 2017 — classified as 2 injuries, 4 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.

• MalfunctionJan 18, 2017Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  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 6260664 ↗
• 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 5804338 ↗
• 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 5458677 ↗
• MalfunctionFeb 18, 2016Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE A2 SEGMENT OF THE CEREBRAL ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COIL DETACHMENT HANDLES (HANDLE). DURING THE PROCEDURE, WHILE ADVANCING A PC400 COIL (LOT # F63825) THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND DECIDED TO REMOVE BOTH THE PX SLIM AND THE PC400 COIL. AFTER REMOVING BOTH DEVICES FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE PC400 COIL WAS DAMAGED AND HAD UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY. A NEW PC400 COIL (LOT # F63825) WAS THEN DEPLOYED INTO THE ANEURYSM USING A NEW PX SLIM WITHOUT ANY ISSUES; HOWEVER, THE PHYSICIAN HAD DIFFICULTY DETACHING THE PC400 COIL IN THE ANEURYSM USING THE HANDLE (LOT # F31442). AFTER THREE UNSUCCESSFUL ATTEMPTS TO DETACH THE PC400 COIL USING THE HANDLE, THE PHYSICIAN ATTEMPTED TO USE A NEW HANDLE (LOT # F31442) BUT WAS STILL UNSUCCESSFUL. THE PC400 COIL WAS THEN DETACHED MANUALLY BY THE PHYSICIAN. ANOTHER PC400 COIL (LOT # F36541) WAS THEN DEPLOYED INTO THE ANEURYSM; HOWEVER, THE PHYSICIAN WAS UNABLE TO DETACH THE COIL USING THE HANDLE AND DECIDED TO MANUALLY DETACH THE COIL. THE PRO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5445493 ↗
• MalfunctionOct 23, 2015Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT FEMORAL ARTERY USING PENUMBRA COIL 400 COILS (PC 400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DELIVERED TWO PC400 COILS INTO THE ANEURYSM. HOWEVER, WHILE ADVANCING A NEW PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND WITHDREW THE PC400 COIL. THE PHYSICIAN THEN SUCCESSFULLY ADVANCED ANOTHER MANUFACTURER'S GUIDEWIRE THROUGH THE PX SLIM AND MADE AN ATTEMPT TO ADVANCE A NEW PC400 COIL THROUGH THE PX SLIM. HOWEVER, THE PHYSICIAN MET RESISTANCE AGAIN AND REMOVED BOTH THE PC400 COIL AND THE PX SLIM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW PX SLIM AND NEW PC400 COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5170457 ↗
• MalfunctionOct 22, 2015Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT FEMORAL ARTERY USING PENUMBRA COIL 400 COILS (PC 400 COILS) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DELIVERED TWO PC400 COILS INTO THE ANEURYSM. HOWEVER, WHILE ADVANCING A NEW PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN MET RESISTANCE AND WITHDREW THE PC400 COIL. THE PHYSICIAN THEN SUCCESSFULLY ADVANCED ANOTHER MANUFACTURER'S GUIDEWIRE THROUGH THE PX SLIM AND MADE AN ATTEMPT TO ADVANCE A NEW PC400 COIL THROUGH THE PX SLIM. HOWEVER, THE PHYSICIAN MET RESISTANCE AGAIN AND REMOVED BOTH THE PC400 COIL AND THE PX SLIM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW PX SLIM AND NEW PC400 COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5169581 ↗