Penumbra Coil 400 4002C0620Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M4244002C06200), received between Nov 25, 2015 and May 16, 2019 — classified as 7 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K103305); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400S (PC400S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A PC400 IN THE LANTERN AND, THEREFORE, THE PC400 WAS REMOVED. THE PHYSICIAN WAS ABLE TO SMOOTHLY ADVANCE A GUIDE WIRE THROUGH THE LANTERN AND, THEREFORE, THE PHYSICIAN ATTEMPTED TO ADVANCE THE PC400 AGAIN. HOWEVER, THE PHYSICIAN AGAIN FELT RESISTANCE AND THE PUSHER ASSEMBLY OF THE PC400 BECAME KINKED. THE LANTERN AND THE PC400 WERE THEN REMOVED, AND THE PHYSICIAN FOUND THAT THE TIP OF THE LANTERN WAS OVALIZED. THE PROCEDURE WAS THEN COMPLETED USING A NEW LANTERN AND NEW PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8617760 ↗
• MalfunctionDec 7, 2017Detachment Of Device Component; Failure to Advance; Physical Resistance; Detachment Of Device Component; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY USING PENUMBRA COIL 400'S (PC400'S). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS BUT NO CALCIFICATION, STENOSIS OR CONSTRICTION OBSERVED. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PC400 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE RIGHT AFTER THE INSERTION OF THE PC400. THE PHYSICIAN THEN RETRACTED THE PC400 BACK INTO ITS INTRODUCER SHEATH AND MADE ANOTHER ATTEMPT TO ADVANCE THE COIL INTO THE LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE PC400 WAS REMOVED. UPON ATTEMPTING TO ADVANCE THE PC400 OUT OF ITS INTRODUCER SHEATH OUTSIDE THE PATIENT¿S BODY, THE PHYSICIAN NOTICED THAT THE PC400 HAD DETACHED. THEREFORE, THE PROCEDURE WAS COMPLETED USING THREE NEW PC400'S 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 7095560 ↗
• MalfunctionOct 25, 2017Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE RIGHT LUMBAR ARTERY USING PENUMBRA COIL 400S (PC400S) AND A PENUMBRA COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT A PC400 HAD UNINTENTIONALLY DETACHED WITHIN THE PACKAGING HOOP WHEN TAKING IT OUT FOR THE PROCEDURE. THE DAMAGE TO THE PC400 OCCURRED PRIOR TO USE AND THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN ADVANCED A NEW PC400 THROUGH THE PX SLIM DELIVERY MICROCATHETER (PX SLIM), HOWEVER THE PHYSICIAN WAS UNABLE TO DETACH THE PC400 USING THE HANDLE, DESPITE ATTEMPTING TO DETACH IT MULTIPLE TIMES. THE PHYSICIAN THEREFORE MANUALLY DETACHED THE PC400. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6978421 ↗
• MalfunctionDec 22, 2016Failure to Advance; Physical Resistance; Device Handling Problem; Failure to Advance; Physical Resistance; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400''S (PC400''S). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED ANOTHER MANUFACTURER'S ANGIOGRAPHIC CATHETER TOWARDS THE IIA AND THEN INSERTED A PX SLIM DELIVERY MICROCATHETER (PX SLIM) THROUGH THE ANGIOGRAPHIC CATHETER. THE PHYSICIAN THEN OPENED THE FIRST PC400, SOAKED THE COIL IN SALINE AND ATTEMPTED TO ADVANCE IT THROUGH THE PX SLIM. HOWEVER, WHILE ATTEMPTING TO ADVANCE THE PC400 OUT OF ITS INTRODUCER SHEATH AND INTO THE PX SLIM, THE PHYSICIAN ADVANCED THE COIL ABOUT FIVE CENTIMETERS FROM THE TIP OF THE INTRODUCER SHEATH AND THEN ENCOUNTERED RESISTANCE. SUBSEQUENTLY, THE PC400 WAS UNABLE TO ADVANCE FURTHER AND WAS RETRACTED. NEXT, THE PHYSICIAN RESOAKED THE PC400 IN SALINE AND MADE ANOTHER ATTEMPT TO ADVANCE THE COIL OUT OF ITS INTRODUCER SHEATH AND INTO THE PX SLIM. HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE PC400 WOULD NOT ADVANCE AT ALL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE COIL WITH FORCE AND INADVERTENTLY KINKED THE PC400 PUSHER ASSEMBLY. THEREFORE, THE PC400 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW PC400 AND THE SAME PX SLIM. IT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6199747 ↗
• MalfunctionAug 2, 2016Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN INITIALLY DELIVERED TWO COILS FROM ANOTHER MANUFACTURER AND TWO PC400 COILS INTO THE TARGET VESSEL USING ANOTHER MANUFACTURER'S MICROCATHETER. WHILE ADVANCING A NEW PC400 COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PC400 COIL BECAME STUCK AROUND THE MIDDLE OF THE MICROCATHETER. THE PHYSICIAN THEN DECIDED TO RETRACT THE PC400 COIL; HOWEVER, WHILE THE COIL WAS BEING RETRACTED, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN FLUSHED THE PC400 COIL OUT OF THE MICROCATHETER USING A SYRINGE AND THEN ATTEMPTED TO ADVANCE A NEW PC400 COIL THROUGH THE MICROCATHETER. HOWEVER, THE NEW PC400 COIL BECAME STUCK AROUND THE TIP OF THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER THEN RETRACTED THE PC400 COIL FROM IT AND COMPLETED THE PROCEDURE USING ANOTHER MANUFACTURER'S COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5842005 ↗
• MalfunctionFeb 19, 2016Retraction Problem; Retraction Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA COIL 400 COILS (PC400 COILS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A PC400 COIL INTO THE ANEURYSM BUT DECIDED TO WITHDRAW THIS COIL AND USE A DIFFERENT SIZED COIL. WHILE THE PC400 COIL WAS BEING RETRACTED BACK INTO ITS INTRODUCER SHEATH, IT BECAME STUCK AND WAS UNABLE TO BE REMOVED. THE PHYSICIAN THEN REMOVED THE PX SLIM TOGETHER WITH THE PC400 COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING FOUR NEW PC400 COILS 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 5449314 ↗
• MalfunctionNov 25, 2015Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  UPON REMOVING A PENUMBRA COIL 400 COIL (PC400 COIL) FROM ITS PACKAGING, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE PC400 COIL PUSHER ASSEMBLY WAS KINKED. THE DAMAGED PC400 COIL WAS FOUND PRIOR TO USE AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PC400 COIL.

  Patient problems: No Patient Involvement

  MAUDE report 5250713 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103305. One submission often covers many models, so check the product and lot details in each record.

• Z-1906-2011 · Mar 4, 2011 · Terminated
  Penumbra brand Penumbra Coil System, Penumbra Coil 400, Product is manufactured and distributed by Penumbra Inc., Alameda, CA The Penumbra Coil System (Penumbra Coil 400 TM) is in