Penumbra System PODH1Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI M424PODH10), received between Aug 19, 2015 and Feb 3, 2021 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE HANDLE BROKE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11273359 ↗
• MalfunctionMar 4, 2020Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD DETACHMENT HANDLE (HANDLE) AND PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST COIL TO THE TARGET VESSEL BUT WAS UNSUCCESSFUL IN DETACHING IT DESPITE MAKING THREE TO FOUR ATTEMPTS WITH THE HANDLE. A SECOND HANDLE WAS THEN OPENED BUT HAD THE SAME ISSUE; SUBSEQUENTLY, THE COIL WAS MANUALLY DETACHED BY KINKING THE PUSHER ASSEMBLY. IT WAS REPORTED THAT PHYSICIAN EXPERIENCED DIFFICULTY DETACHING SUBSEQUENT COILS WITH THE SECOND HANDLE; THEREFORE, THEY WERE MANUALLY DETACHED. THE PROCEDURE WAS COMPLETED BY MANUALLY DETACHING THE COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9787015 ↗
• MalfunctionMar 4, 2020Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD DETACHMENT HANDLE (HANDLE) AND PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST COIL TO THE TARGET VESSEL BUT WAS UNSUCCESSFUL IN DETACHING IT DESPITE MAKING THREE TO FOUR ATTEMPTS WITH THE HANDLE. A SECOND HANDLE WAS THEN OPENED BUT HAD THE SAME ISSUE; SUBSEQUENTLY, THE COIL WAS MANUALLY DETACHED BY KINKING THE PUSHER ASSEMBLY. IT WAS REPORTED THAT PHYSICIAN EXPERIENCED DIFFICULTY DETACHING SUBSEQUENT COILS WITH THE SECOND HANDLE; THEREFORE, THEY WERE MANUALLY DETACHED. THE PROCEDURE WAS COMPLETED BY MANUALLY DETACHING THE COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9787010 ↗
• MalfunctionNov 1, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD10S AND A POD DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO POD10S INTO THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED A NEW POD10 INTO THE TARGET VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE POD10 FAILED TO DETACH. AFTER MULTIPLE FAILED ATTEMPTS TO DETACH THE POD10, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE POD10; HOWEVER, THE POD10 WOULD NOT DETACH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A RUBY COIL, A POD PACKING COIL 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 9268934 ↗
• MalfunctionMar 22, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  WHILE REMOVING A POD DETACHMENT HANDLE (HANDLE) FROM ITS PACKAGING DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HANDLE NOSE CONE FELL OFF. THE DAMAGE TO THE HANDLE WAS FOUND PRIOR TO USE AND, THEREFORE, WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE.

  Patient problems: No Patient Involvement

  MAUDE report 8444477 ↗
• MalfunctionJan 15, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A POD DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN REMOVED THE HANDLE FROM ITS PACKAGING AND FOUND THAT THE PROXIMAL END OF THE HANDLE WAS BROKEN; HOWEVER, THE PHYSICIAN TRIED TO RE-ASSEMBLE IT AND USE IT. WHILE ATTEMPTING TO DETACH A POD8 USING THE HANDLE, THE POD8 PUSHER ASSEMBLY CAME THROUGH THE BACK OF THE HANDLE. THEREFORE, THE HANDLE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER HANDLE TO DETACH THE SAME POD8. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8249475 ↗
• MalfunctionJan 11, 2019Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD DETACHMENT HANDLE (HANDLE) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DETACHED TWO RUBY COILS INTO THE TARGET VESSEL USING THE HANDLE. HOWEVER, AFTER THE PHYSICIAN DETACHED THE THIRD RUBY COIL USING THE HANDLE, THE PUSHER WIRE BECAME STUCK INSIDE THE HANDLE. THE HANDLE AND PUSHER WIRE WERE THEN REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8240906 ↗
• MalfunctionNov 2, 2018Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE ON THE SPLENIC ARTERY USING A POD5 AND POD DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH THE POD5 USING THE HANDLE. IT WAS ALSO REPORTED THAT THE HANDLE WOULD NOT CLICK. THEREFORE, THE HANDLE WAS REMOVED, AND A NEW HANDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8035681 ↗
• MalfunctionSep 11, 2018Difficult or Delayed Activation; Difficult or Delayed Activation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A PENUMBRA COIL 400 DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL TO THE TARGET LOCATION USING A LANTERN DELIVERY MICROCATHETER. THE PHYSICIAN THEN WAS UNABLE TO DETACH THE RUBY COIL USING THE HANDLE AND, THEREFORE, THE PHYSICIAN OPENED A NEW HANDLE. THE RUBY COIL WAS ABLE TO BE DETACHED USING THE NEW HANDLE, AND THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL RUBY COILS, POD PACKING COILS (PODJS), THE SAME HANDLE, 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 7866662 ↗
• MalfunctionJun 19, 2018Break; Break

  DURING A COIL EMBOLIZATION PROCEDURE, THE PHYSICIAN NOTED THAT THE DISTAL PART OF THE POD DETACHMENT HANDLE (HANDLE) WAS MISSING UPON REMOVAL FROM THE PACKAGING. IT WAS FOUND LATER THAT THE DISTAL PART OF THE HANDLE WAS DISCONNECTED FROM THE HANDLE AND WAS INSIDE THE PACKAGING. THE REPORTED ISSUE WAS FOUND PRIOR TO USE. THEREFORE, THE HANDLE WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE.

  Patient problems: No Patient Involvement

  MAUDE report 7615667 ↗
• MalfunctionApr 25, 2018Device Damaged Prior to Use; Contamination /Decontamination Problem; Device Handling Problem; Device Damaged Prior to Use; Contamination /Decontamination Problem; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE POD PACKING COIL (PODJ) WAS ACCIDENTALLY DROPPED ON THE FLOOR AND THE POD DETACHMENT HANDLE (HANDLE) WAS MANUALLY CONTAMINATED UPON REMOVAL FROM THE PACKAGING. THE REPORTED ISSUES OCCURRED PRIOR TO USE AND THEREFORE, THE PODJ AND THE HANDLE WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING NEW PODJ, RUBY COIL AND RUBY COIL DETACHMENT HANDLE (HANDLE).

  Patient problems: No Patient Involvement

  MAUDE report 7461702 ↗
• MalfunctionJan 8, 2018Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL DETACHMENT HANDLES (RUBY HANDLES), A POD DETACHMENT HANDLE (POD HANDLE) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED MULTIPLE RUBY COILS USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A POD HANDLE. THE PHYSICIAN THEN WAS UNABLE TO DETACH A RUBY COIL, DESPITE ATTEMPTING TO DETACH IT USING THE SAME HANDLE, AND TWO OTHER NEW HANDLES (F79851, F78388). THE RUBY COIL WAS EVENTUALLY ABLE TO BE DETACHED USING A FOURTH RUBY COIL HANDLE (F79489). THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL RUBY COIL AND THE SAME FOURTH HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7172160 ↗
• MalfunctionJun 20, 2017Mechanical Problem; Device Operates Differently Than Expected; Mechanical Problem; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD DETACHMENT HANDLE (PODH1) AND POD8 COILS (POD8¿S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED A POD8 INTO THE TARGET VESSEL AND THEN USED THE PODH1 TO DETACH THE COIL. IT WAS OBSERVED THAT THE BLACK MARKER ON THE PUSHER ASSEMBLY SEPARATED. HOWEVER, WHEN THE PUSHER ASSEMBLY WAS REMOVED FROM THE PATIENT, THE POD8 WAS STILL ATTACHED. THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL COILS AND THE SAME PODH1. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6654877 ↗
• MalfunctionMay 13, 2016Mechanical Problem; Retraction Problem; Device Operates Differently Than Expected; Mechanical Problem; Retraction Problem; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND A POD DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, WHILE BEING RETRACTED THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), A RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE DETACHED RUBY COIL WAS REMOVED FROM THE LANTERN AND A NEW RUBY COIL WAS DEPLOYED AND DETACHED INTO THE ANEURYSM; HOWEVER, AFTER THE RUBY COIL WAS DETACHED, THE RUBY COIL PUSHER ASSEMBLY BECAME STUCK IN THE HANDLE AND COULD NOT BE REMOVED. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5654184 ↗
• MalfunctionMay 3, 2016Mechanical Problem; Difficult to Remove; Mechanical Problem; Difficult to Remove

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD DETACHMENT HANDLE (POD HANDLE) AND A RUBY COIL DETACHMENT HANDLE (RUBY HANDLE). DURING THE PROCEDURE, AFTER THE PHYSICIAN DETACHED A RUBY COIL USING THE POD HANDLE, THE RUBY COIL PUSHER ASSEMBLY BECAME STUCK IN THE POD HANDLE. THE POD HANDLE WAS REMOVED AND A NEW RUBY HANDLE WAS OPENED; HOWEVER, THE RUBY HANDLE DID NOT MAKE THE USUAL "CLICKING" SOUND AND WAS NOT USED. THEREFORE, A THIRD RUBY HANDLE WAS USED TO DETACH ADDITIONAL RUBY COILS, ONE POD COIL AND ONE POD PACKING COIL. THE PROCEDURE WAS THEN COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5625749 ↗
• MalfunctionAug 19, 2015Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD DETACHMENT HANDLE. DURING PREPARATION FOR THE PROCEDURE, THE PHYSICIAN TESTED THE DETACHMENT HANDLE BY PULLING THE TRIGGER; HOWEVER, THE DETACHMENT HANDLE DID NOT MAKE THE USUAL CLICKING NOISE AND, THEREFORE, IT WAS NOT USED. THE PROCEDURE SUCCESSFULLY CONTINUED USING A PENUMBRA COIL 400 DETACHMENT HANDLE.

  Patient problems: No Patient Involvement

  MAUDE report 5016415 ↗