Penumbra System RH1-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI M424RH10), received between Aug 17, 2015 and Nov 30, 2021 — classified as 154 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (112 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL, POD COILS, POD PACKING COILS (POD PCS), A RUBY COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL, AND SIX POD COILS INTO THE TARGET VESSEL USING A MICROCATHETER. THE PHYSICIAN THEN ADVANCED A POD PC INTO THE TARGET VESSEL USING THE MICROCATHETER AND USED A HANDLE TO DETACH IT. HOWEVER, THE POD PC FAILED TO DETACH AFTER SEVERAL ATTEMPTED WERE MADE. IT WAS REPORTED THAT THE PHYSICIAN MANUALLY CHECKED THE SEPARATOR ON THE BLACK ALIGNMENT ZONE, BUT THE DELIVERY WIRE COULD NOT BE PULLED OUT FROM THE HANDLE. SUBSEQUENTLY, THE POD PC UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER WHEN PULLING ON THE DELIVERY WIRE. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD PC WAS REMOVED AND THE POD PC WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING SIX POD PCS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12901952 ↗
• MalfunctionNov 23, 2021Mechanical Problem; Separation Failure; Mechanical Problem; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE POD COIL IN THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE POD COIL FAILED TO DETACH. IT WAS NOTICED THAT THE BLACK ALIGNMENT ZONE ON THE POD COIL WAS SEPARATED; HOWEVER, IT WAS NOTED UNDER FLUOROSCOPY THAT THE POD COIL STILL DID NOT DETACH. AFTERWARDS, THE PHYSICIAN WAS ABLE TO MANUALLY DETACH THE POD COIL BY PULLING THE WIRE MULTIPLE TIMES. IT WAS REPORTED THAT TWO OTHER PENUMBRA COILS HAD DIFFICULTY DETACHING WITH THE HANDLE; HOWEVER, THE COILS WERE ABLE TO DETACH ON THE SECOND ATTEMPT. THE PROCEDURE WAS COMPLETED USING MORE RUBY COILS AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863535 ↗
• MalfunctionNov 23, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING A RUBY COIL DETACHMENT HANDLE (HANDLE), RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE RUBY COIL PUSHER WIRE WAS STUCK INSIDE THE HANDLE. HOWEVER, THE PHYSICIAN WAS ABLE TO MANUALLY DETACH THE RUBY COIL AND SUCCESSFULLY IMPLANT IT INTO THE TARGET LOCATION. AT THIS POINT, THE PROCEDURE WAS FINISHED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863040 ↗
• MalfunctionNov 19, 2021Difficult to Remove; Difficult to Remove

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT CORONARY AND CIRCUMFLEX FISTULA USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), POD COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED A POD COIL IN THE TARGET VESSEL USING THE HANDLE. SUBSEQUENTLY, THE PHYSICIAN DETACHED A RUBY COIL USING THE HANDLE; HOWEVER, THE PUSHER ASSEMBLY OF A RUBY COIL WAS STUCK INSIDE THE HANDLE AFTER THE PHYSICIAN HAD SUCCESSFULLY DETACHED THE RUBY COIL. THEREFORE, THE HANDLE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, A POD COIL, AND A POD PACKING COIL (POD PC). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849369 ↗
• MalfunctionNov 9, 2021Difficult to Remove; Difficult to Remove

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL TO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL TO THE TARGET VESSEL AND SUCCESSFULLY DETACHED IT USING THE HANDLE. HOWEVER, AFTER THE DETACHMENT, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME STUCK IN THE HANDLE. THEREFORE, THE HANDLE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. IT WAS REPORTED THAT THE HANDLE WAS UNABLE TO FULLY COVER THE PUSHER ASSEMBLIES OF THE RUBY COILS AND THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE PUSHER ASSEMBLIES OF THE RUBY COILS INTO THE HANDLE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12778943 ↗
• MalfunctionOct 19, 2021Mechanical Problem; Separation Failure; Mechanical Problem; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL DETACHMENT HANDLE (HANDLE) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING EIGHT RUBY COILS AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661732 ↗
• MalfunctionOct 3, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING POD PACKING COILS (POD PC), RUBY COIL DETACHMENT HANDLE (HANDLE), AND NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A POD PC THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD PC WOULD NOT ADVANCE OUT THE DISTAL TIP OF THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO DETACH THE POD PC INSIDE THE MICROCATHETER USING A HANDLE; HOWEVER, THE POD PC FAILED TO DETACH. CONSEQUENTLY, AFTER MULTIPLE ATTEMPTS, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE POD PC. THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING PENUMBRA SMART COILS (SMART COIL), A PENUMBRA SMART COIL DETACHMENT HANDLE (HANDLE), AN ADDITIONAL NON-PENUMBRA MICROCATHETER, AND THE SAME CARNELIAN HF MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12566506 ↗
• MalfunctionSep 30, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING A RUBY COIL DETACHMENT HANDLE (HANDLE), RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN MADE FOUR TO FIVE UNSUCCESSFUL ATTEMPTS TO DETACH THE FIRST RUBY COIL USING THE HANDLE. THEREFORE, THE HANDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, THE SAME RUBY COIL, THE SAME LANTERN, AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558354 ↗
• MalfunctionSep 21, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE VERTEBRAL ARTERY USING A RUBY COIL DETACHMENT HANDLE (HANDLE), A POD COIL AND A NON-PENUMBRA MICROCATHETER (PHENOM). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL INTO THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE POD COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN USED A NEW HANDLE TO DETACH THE POD COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL POD COILS AND THE NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12508485 ↗
• MalfunctionSep 14, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN AND INFERIOR VENA CAVA (IVA) SHUNT USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND STENOSED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE RUBY COIL INTO THE TARGET LOCATION USING THE HANDLE. WHILE ATTEMPTING TO IMPLANT THE NEXT RUBY COIL, THE HANDLE FAILED TO DETACH THE COIL. IT WAS ALSO REPORTED THAT THE RUBY COIL PUSHER ASSEMBLY BECAME STUCK INSIDE THE HANDLE. WHILE ATTEMPTING TO REMOVE THE RUBY COIL, THE PHYSICIAN REALIZED THAT THE COIL WAS STRETCHED INSIDE THE LANTERN. THEREFORE, THE LANTERN AND THE RUBY COIL WERE REMOVED TOGETHER FROM THE PATIENT. THE HANDLE WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, FIVE RUBY COILS, ANOTHER HANDLE, AND SIXTEEN NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468675 ↗
• MalfunctionSep 9, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL VEIN USING A RUBY COIL DETACHMENT HANDLE (HANDLE), RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. THEREFORE, THE RUBY COIL AND HANDLE WERE REMOVED. SUBSEQUENTLY, WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL BECAME STUCK. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED. THE PHYSICIAN THEN INSERTED A NEW MICROCATHETER AND ATTEMPTED TO ADVANCE ANOTHER RUBY COIL; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN REMOVED THE RUBY COIL AND MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE, NEW RUBY COILS AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447534 ↗
• MalfunctionSep 7, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL DETACHMENT HANDLE (HANDLE) AND RUBY COILS. IT WAS REPORTED THE PATIENT ANATOMY WAS DIFFICULT. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED ONE COIL IN THE TARGET LOCATION. SUBSEQUENTLY, THE NEXT COIL, A RUBY COIL, WOULD NOT DETACH WITH THE HANDLE. THEREFORE, THE HANDLE WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A SECOND HANDLE AND THE SAME RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436212 ↗
• MalfunctionSep 1, 2021Mechanical Problem; Separation Failure; Mechanical Problem; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL DETACHMENT HANDLE (HANDLE), POD COILS, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE POD COIL FAILED TO DETACH AFTER MULTIPLE ATTEMPTS. IT WAS REPORTED THAT THE COIL ALIGNMENT ZONE SEPARATED, BUT THE POD COIL DID NOT DETACH. THEREFORE, THE PHYSICIAN PULLED THE PUSHER ASSEMBLY OF THE POD COIL WITH THE HANDLE TO DETACH IT. IT WAS ALSO REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE INSERTING THE PROXIMAL END OF THE PUSHER ASSEMBLY INTO THE HANDLE. NEXT, THE PHYSICIAN ADVANCED ANOTHER POD COIL TO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE PHYSICIAN ALSO PULLED THE PUSHER ASSEMBLY OF THE POD COIL WITH THE HANDLE TO DETACH IT. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDLE AND EIGHT ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12411370 ↗
• MalfunctionAug 24, 2021Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A RUBY COIL DETACHMENT HANDLE (HANDLE), POD PACKING COILS (POD PCS), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN MADE THREE ATTEMPTS TO DETACH THE FIRST POD PC WITH THE HANDLE WITHOUT SUCCESS. THE POD PC WAS DETACHED MANUALLY AND THE HANDLE WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING OTHER COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12363202 ↗
• MalfunctionJul 23, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT PULMONARY ARTERY USING POD COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE LOADING A POD COIL INTO A MICROCATHETER, THE NEW RESIDENT KINKED THE POD COIL. THEREFORE, THE POD COIL WAS REMOVED. NEXT, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED THREE PENUMBRA COILS IN THE TARGET LOCATION USING THE MICROCATHETER. THE PHYSICIAN THEN ADVANCED ANOTHER PENUMBRA COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE PENUMBRA COIL FAILED TO DETACH. THEREFORE, THE PHYSICIAN USED A NEW HANDLE TO DETACH THE PENUMBRA COIL. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, THE SECOND HANDLE AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218158 ↗
• MalfunctionJul 21, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL DETACHMENT HANDLE (HANDLE) AND RUBY COILS. DURING THE PROCEDURE, THE PUSHER ASSEMBLY OF A RUBY COIL WAS STUCK INSIDE THE HANDLE AFTER THE PHYSICIAN HAD SUCCESSFULLY DETACHED THE RUBY COIL. THEREFORE, THE HANDLE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207327 ↗
• MalfunctionJun 23, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY (IIA) USING A RUBY COIL DETACHMENT HANDLE (HANDLE) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THE RUBY COIL USING THE HANDLE AND AN UNUSUAL SOUND WAS HEARD COMING FROM THE HANDLE. THE PHYSICIAN WITHDREW THE RUBY COIL PUSHER ASSEMBLY AND REALIZED THE COIL DID NOT DETACH. THEREFORE, THE RUBY COIL WAS RE-ADVANCED INTO THE TARGET LOCATION AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING THE HANDLE THREE TIMES WITHOUT SUCCESS. THEREFORE, THE HANDLE WAS REMOVED AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER HANDLE TO DETACH THE SAME RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054510 ↗
• MalfunctionJun 18, 2021Mechanical Problem; Physical Resistance/Sticking; Mechanical Problem; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM), A RUBY COIL AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL TO THE TARGET VESSEL USING A PX SLIM AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME STUCK WITHIN THE HANDLE. THEREFORE, THE RUBY COIL AND THE HANDLE WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL, A NEW HANDLE AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12025781 ↗
• MalfunctionMay 18, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY USING A RUBY COIL DETACHMENT HANDLE (HANDLE) AND RUBY COIL. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DETACH THE FIRST RUBY COIL WITH THE HANDLE. IT WAS REPORTED THE HANDLE MADE A STRANGE SOUND, AND THE RUBY COIL WAS NOT DETACHED. THEREFORE, THE HANDLE WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND THE SAME RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11845758 ↗
• MalfunctionMay 11, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD8 COIL INTO THE OUTFLOW VESSEL, BUT THE POD8 COIL WOULD NOT FORM TO THE VESSEL DUE TO SIZING AND WAS REMOVED. AFTERWARDS, THE PHYSICIAN ADVANCED A POD6 COIL INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE HANDLE WOULD NOT CLICK WHEN THE TRIGGER WAS PULLED. SUBSEQUENTLY, THE POD6 COIL FAILED TO DETACH. THEREFORE, THE HANDLE WAS REMOVED AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME POD6 COIL AND A NEW HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810142 ↗
• MalfunctionApr 27, 2021Difficult to Remove; Difficult to Remove

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING A RUBY COIL DETACHMENT HANDLE (HANDLE), RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN USED THE HANDLE TO SUCCESSFULLY IMPLANT SEVEN COILS INTO THE TARGET VESSEL. WHILE ATTEMPTING TO DETACH THE NEXT RUBY COIL, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME STUCK IN THE HANDLE. THEREFORE, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734425 ↗
• MalfunctionApr 7, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAROTID-CAVERNOUS FISTULA (CCF) USING PENUMBRA COIL 400 DETACHMENT HANDLES (HANDLES), A RUBY COIL DETACHMENT HANDLE (HANDLE), A PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND PENUMBRA COILS 400 (PC400S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED A PC400 INTO THE TARGET LOCATION USING THE HANDLE. HOWEVER, THE HANDLE BECAME JAMMED WITH THE PUSHER ASSEMBLY OF THE PC400 THAT WAS STUCK IN THE HANDLE. AFTER THAT, THE SCRUB TECHNOLOGIST REMOVED THE PUSHER ASSEMBLY OF THE PC400 WITH THE HANDLE ATTACHED FROM THE PX SLIM. NEXT, THE PHYSICIAN SUCCESSFULLY DEPLOYED ANOTHER PC400 INTO THE TARGET LOCATION USING A SECOND HANDLE. HOWEVER, THE SAME ISSUE OCCURRED. THE HANDLE BECAME JAMMED WITH THE PUSHER ASSEMBLY OF THE PC400. SUBSEQUENTLY, THE SCRUB TECHNOLOGIST BROKE THE PUSHER ASSEMBLY OF THE PC400 AN INCH FROM THE HANDLE AND SET IT ASIDE. AFTERWARDS, THE PHYSICIAN SUCCESSFULLY DEPLOYED ANOTHER PC400 INTO THE TARGET LOCATION USING A THIRD HANDLE. HOWEVER, THE SAME ISSUE OCCURRED. THE HANDLE BECAME JAMMED WITH THE PUSHER ASSEMBLY OF THE PC400. CONSEQUENTLY, THE SCRUB TECHNOLOGIST WAS NOT ABLE TO PULL OUT THE PUSHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11627632 ↗
• MalfunctionMar 16, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A RUBY COIL, A RUBY COIL DETACHMENT HANDLE (HANDLE) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL IN THE TARGET VESSEL USING THE MICROCATHETER AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE RUBY COIL FAILED TO DETACH. NEXT, THE PHYSICIAN KEPT CLICKING THE HANDLE AND THE RUBY COIL EVENTUALLY DETACHED. THE PHYSICIAN THEN REMOVED THE HANDLE AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, AND BY MANUALLY DETACHING ADDITIONAL RUBY COILS AND POD PACKING COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499460 ↗
• MalfunctionMar 9, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH THE RUBY COIL USING THE HANDLE AFTER SEVERAL ATTEMPTS WERE MADE. THEREFORE, THE HANDLE WAS REMOVED. IT IS UNKNOWN WHETHER THE HANDLE SUCCESSFULLY DETACHED ANY COILS PRIOR TO THE COMPLAINT COIL. THE PROCEDURE WAS COMPLETED BY USING ANOTHER HANDLE TO DETACH THE SAME RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11448564 ↗
• MalfunctionMar 9, 2021Mechanical Problem; Mechanical Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY USING POD PACKING COILS (POD PCS), A RUBY COIL DETACHMENT HANDLE (HANDLE), A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COILS AND FIVE POD PCS USING A RE-STERILIZED HANDLE. AFTER ADVANCING THE SAME THE HANDLE OVER THE PROXIMAL END OF A POD PC PUSHER ASSEMBLY, RESISTANCE WAS ENCOUNTERED. THEREFORE, THE HANDLE WAS REMOVED. IT WAS REPORTED THAT THE HANDLE HAD BEEN USED IN ANOTHER CASE AND RE-STERILIZED BEFORE USE IN THIS CASE. THE PHYSICIAN ATTEMPTED TO USE A NEW HANDLE TO DETACH THE POD PC BUT WAS UNSUCCESSFUL. WHILE ATTEMPTING TO RETRACT THE POD PC, THE PUSHER ASSEMBLY BROKE AT THE HUB OF THE MICROCATHETER. THE PHYSICIAN USED FORCEPS AND A NEEDLE TO REMOVE THE BROKEN PUSHER ASSEMBLY FROM THE MICROCATHETER. UPON REMOVAL, THE COIL DETACHED. FLUOROSCOPY REVEALED THAT THE LAST THREE CENTIMETERS OF THE POD PC REMAINED INSIDE THE DISTAL TIP OF THE MICROCATHETER. THEREFORE, A GUIDEWIRE WAS USED TO IMPLANT THE POD PC INTO THE TARGET LOCATION. AT THIS POINT, THE PROCEDURE WAS ENDED. THERE WAS NO REPORT OF AN ADVER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445719 ↗

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