Penumbra Coil 400 4002C0720Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI M4244002C07200), received between Sep 19, 2015 and Aug 19, 2019 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY USING PENUMBRA COIL 400 (PC400) COILS. THE PROCEDURE WAS SUCCESSFUL WITH NO COMPLICATIONS. HOWEVER, THE NEXT DAY, MAGNETIC RESONANCE IMAGING REVEALED SMALL FOCI OF SILENT ISCHEMIA IN THE LEFT CEREBRAL HEMISPHERE OF THE PATIENT. THE RELATIONSHIP OF THE PC400 COILS TO THE ISCHEMIA IS UNCERTAIN; HOWEVER THE RELATIONSHIP OF THE PROCEDURE TO THE ISCHEMIA IS DEFINITE.

  Patient problems: Ischemia

  MAUDE report 8905884 ↗
• MalfunctionApr 10, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY USING PENUMBRA COILS 400 (PC400¿S). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE APPROXIMATELY 10 CENTIMETERS FROM THE DISTAL TIP OF THE LANTERN AND THE PC400 WOULD NOT ADVANCE; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PC400 THROUGH LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED AT THE SAME POSITION AND PC400 WOULD NOT ADVANCE FURTHER. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7412348 ↗
• InjuryMar 8, 2018Detachment Of Device Component; Unintended Movement; Detachment Of Device Component; Unintended Movement

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) TO TREAT A ABDOMINAL AORTIC ANEURYSM (AAA) USING PENUMBRA COIL 400S (PC400S). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE A PC400 IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER, HOWEVER THE PC400 WAS PROTRUDING OUT OF THE TARGET LOCATION TOWARD THE COMMON ILIAC ARTERY (CIA). AFTER ATTEMPTING TO MANIPULATE THE PC400 MULTIPLE TIMES, THE PC400 UNINTENTIONALLY DETACHED WHILE THE PC400 WAS ADVANCED ABOUT 17 CM OUT OF THE TIP OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO REMOVE THE MICROCATHETER WITH THE PC400 INSIDE, HOWEVER THE PC400 REMAINED INSIDE OF THE PATIENT. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE PC400. THE PROCEDURE WAS THEN COMPLETED USING THE SAME MICROCATHETER, ADDITIONAL COILS AND NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7324300 ↗
• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE USING PENUMBRA COIL 400''S (PC400''S) WITH NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. ON (B)(6) 2017, THE PATIENT PRESENTED AT THE HOSPITAL WITH A RIGHT ARM AND LEG SENSATION CHANGE. THE RIGHT ARM SENSATION RESOLVED SPONTANEOUSLY; HOWEVER, THE PATIENT HAD DECREASED SENSATION BELOW THE KNEE AND A COLD FEELING WAS PRESENT. THE PATIENT''S NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE AT BASELINE WAS A 3. THE RESULTS OF THE COMPUTERIZED TOMOGRAPHY (CT) HEAD AND COMPUTERIZED TOMOGRAPHY ANGIOGRAPHY (CTA) WERE NEGATIVE AT BASELINE. THE PATIENT WAS GIVEN INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV-TPA) AND THE SYMPTOMS RESOLVED ON (B)(6) 2017. THE REPORTED FOCAL NEUROLOGICAL DEFICIT WAS ADJUDICATED TO BE AN ADVERSE EVENT THAT WAS POSSIBLY RELATED TO THE PC400 BUT UNRELATED TO THE PROCEDURE.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 7033340 ↗
• MalfunctionAug 16, 2017Difficult to Remove; Difficult or Delayed Activation; Mechanical Jam; Difficult to Remove; Difficult or Delayed Activation; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ANTERIOR COMMUNICATING ARTERY (ACOM) USING PENUMBRA COIL 400'S (PC400S) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A PC400 INTO THE TARGET VESSEL AND THEN ATTEMPTED TO DETACH THE COIL USING THE HANDLE; HOWEVER, THE PC400 PUSHER ASSEMBLY GOT STUCK IN THE HANDLE AND THE COIL DID NOT DETACH. THE PHYSICIAN THEN ATTEMPTED TO PULL THE PUSHER ASSEMBLY OUT OF THE HANDLE BUT IT WAS STUCK. THEREFORE, THE PHYSICIAN BROKE THE END OF THE PUSHER ASSEMBLY AND MANUALLY DETACHED THE PC400. THE PROCEDURE WAS THEN SUCCESSFULLY COMPLETED USING ADDITIONAL PC400''S AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6798958 ↗
• MalfunctionApr 6, 2017Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400''S (PC400''S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED FIVE PC400''S INTO THE TARGET VESSEL USING A NON-PENUMBRA CATHETER AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). THE PHYSICIAN THEN HAD DEPLOYED A SIXTH PC400 (LOT # A25537) INTO THE PATIENT BUT HAD DIFFICULTY DETACHING THE COIL USING THE SAME HANDLE. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS ABLE TO DETACH THE COIL. NEXT, THE PHYSICIAN DEPLOYED A SEVENTH PC400 (LOT # F70957) INTO THE PATIENT AND ATTEMPTED TO DETACH THE COIL USING THE SAME HANDLE. HOWEVER, AFTER SEVERAL ATTEMPTS, THE PC400 WAS UNABLE TO DETACH AND WAS REMOVED. THEREAFTER, THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6465507 ↗
• InjuryDec 28, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE POSTERIOR BASILAR ARTERY USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED THREE PC400 COILS INTO THE ANEURYSM WITH NO IMMEDIATE COMPLICATIONS. HOWEVER, AFTER THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED MODERATE HYDROCEPHALUS. A VENTRICULOSTOMY WAS PERFORMED AND THE EVENT WAS RESOLVED ON (B)(6) 2012. THE REPORTED MODERATE HYDROCEPHALUS WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT WITH POSSIBLE RELATIONSHIP TO THE PC400 COILS, PROBABLE RELATIONSHIP TO ANGIOGRAPHIC PROCEDURE AND DEFINITE RELATIONSHIP TO THE ANEURYSM STATE.

  Patient problems: Hydrocephalus

  MAUDE report 5330849 ↗
• MalfunctionNov 30, 2015Fracture; Kinked

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A RENAL ARTERIOVENOUS FISTULA (AVF) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED ONE PC400 COIL INTO THE ANEURYSM USING A PX SLIM DELIVERY MICROCATHETER. WHILE ADVANCING A NEW PC400 COIL THROUGH THE PX SLIM, THE PHYSICIAN NOTICED THAT THE PC400 COIL PUSHER ASSEMBLY WAS KINKED; HOWEVER, THE PHYSICIAN CONTINUED TO ADVANCE THE PC400 COIL UNTIL RESISTANCE WAS MET AND THE PUSHER ASSEMBLY THEN BECAME FRACTURED. THE PHYSICIAN REMOVED BOTH THE PC400 COIL AND THE PX SLIM FROM THE PATIENT. 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 5256189 ↗
• InjurySep 19, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY USING PENUMBRA COIL 400 (PC400) COILS. THE PROCEDURE WAS SUCCESSFUL WITH NO COMPLICATIONS. HOWEVER, THE NEXT DAY, MAGNETIC RESONANCE IMAGING REVEALED SMALL FOCI OF SILENT ISCHEMIA IN THE LEFT CEREBRAL HEMISPHERE OF THE PATIENT. THE RELATIONSHIP OF THE PC400 COILS TO THE ISCHEMIA IS UNCERTAIN; HOWEVER THE RELATIONSHIP OF THE PROCEDURE TO THE ISCHEMIA IS DEFINITE.

  Patient problems: Ischemia

  MAUDE report 5089845 ↗