Ruby XL Coil SystemRecalls & reported problems across all models

We found 14 models of Ruby XL Coil System by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Jul 29, 2025 and Sep 22, 2026 — classified as 1 injury, 36 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Ruby XL Coil System problems

Ruby XL Coil System models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Ruby XL Coil System RBYPCXL55-A

  Device, Vascular, For Promoting Embolization
  6 reports
• Ruby XL Coil System RBYPCXL45-A

  Device, Vascular, For Promoting Embolization
  5 reports
• Ruby XL Coil System RBYPCXL30-A

  Device, Vascular, For Promoting Embolization
  4 reports
• Ruby XL Coil System RBYPCXL70-A

  Device, Vascular, For Promoting Embolization
  4 reports
• Ruby XL Coil System RBYXL4070-A

  Device, Vascular, For Promoting Embolization
  3 reports
• Ruby XL Coil System RBYPODXL0855-A

  Device, Vascular, For Promoting Embolization
  3 reports
• Ruby XL Coil System RBYPODXL0410-A

  Device, Vascular, For Promoting Embolization
  2 reports
• Ruby XL Coil System RBYPODXL0655-A

  Device, Vascular, For Promoting Embolization
  2 reports
• Ruby XL Coil System RBYPODXL0870-A

  Device, Vascular, For Promoting Embolization
  2 reports
• Ruby XL Coil System RBYPODXL1055-A

  Device, Vascular, For Promoting Embolization
  2 reports
• Ruby XL Coil System RBYXL2455-A

  Device, Vascular, For Promoting Embolization
  1 report
• Ruby XL Coil System RBYXL3255-A

  Device, Vascular, For Promoting Embolization
  1 report
• Ruby XL Coil System RBYPODXL1255-A

  Device, Vascular, For Promoting Embolization
  1 report
• Ruby XL Coil System RBYPODXL1655-A

  Device, Vascular, For Promoting Embolization
  1 report

Recent Ruby XL Coil System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Premature Separation

  The patient was undergoing a coil embolization procedure in the gastric varices using a Packing Coil XL, Ruby XL, and a non-Penumbra diagnostic catheter. While advancing a Packing Coil XL to the target location, the physician encountered resistance. Upon retraction, the embolization coil unintentionally detached within the diagnostic catheter. The physician subsequently used saline to flush the detached Packing Coil XL into the vessel.While advancing the a Ruby XL, resistance was encountered again. The Ruby XL was retracted and it unintentionally detached within the diagnostic catheter. The physician subsequently used saline to flush the detached Ruby XL into the vessel.The procedure was completed using a new non-Penumbra coil and the same diagnostic catheter. There was no report of an adverse effect to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852406 ↗
• MalfunctionSep 22, 2026Premature Separation

  The patient was undergoing a coil embolization procedure in the gastric varices using a Packing Coil XL, Ruby XL, and a non-Penumbra diagnostic catheter. While advancing a Packing Coil XL to the target location, the physician encountered resistance. Upon retraction, the embolization coil unintentionally detached within the diagnostic catheter. The physician subsequently used saline to flush the detached Packing Coil XL into the vessel.While advancing the a Ruby XL, resistance was encountered again. The Ruby XL was retracted and it unintentionally detached within the diagnostic catheter. The physician subsequently used saline to flush the detached Ruby XL into the vessel.The procedure was completed using a new non-Penumbra coil and the same diagnostic catheter. There was no report of an adverse effect to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852399 ↗
• MalfunctionJun 2, 2026Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING A PACKING COIL XL, A POD XL AND A NON- PENUMBRA CATHETER (5FR). IT WAS REPORTED THAT THE COILS WOULD NOT STAY AT THE INTENDED LOCATION AND MIGRATED TO ANOTHER BRANCH OF THE PULMONARY ARTERY. THE PHYSICIAN REMOVED BOTH COILS USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING RUBY COILS 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 25368249 ↗
• MalfunctionJun 2, 2026Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING A PACKING COIL XL, A POD XL AND A NON- PENUMBRA CATHETER (5FR). IT WAS REPORTED THAT THE COILS WOULD NOT STAY AT THE INTENDED LOCATION AND MIGRATED TO ANOTHER BRANCH OF THE PULMONARY ARTERY. THE PHYSICIAN REMOVED BOTH COILS USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED USING RUBY COILS 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 25368247 ↗
• MalfunctionJun 2, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN TWO VARICES OF THE LEFT RENAL VEIN USING A POD XL COIL (POD XL), A NON-PENUMBRA CATHETER (4FR), AND A NON-PENUMBRA SHEATH (7FR). THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE COILS IN THE FIRST VARIX. THE CATHETER WAS THEN REPOSITIONED TO THE SECOND VARIX AND PLACED ONE NON-PENUMBRA COIL. WHILE ADVANCING THE POD XL THROUGH THE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE CAUSING THE COIL'S PUSHER ASSEMBLY TO KINK. SUBSEQUENTLY, THE POD XL UNINTENTIONALLY DETACHED WITHIN THE CATHETER. THE CATHETER WAS REMOVED; HOWEVER, THE EMBOLIZATION COIL REMAINED WITHIN THE SHEATH. THE SHEATH CONTAINING THE EMBOLIZATION COIL WAS REMOVED FROM THE PATIENT. ACCESS WAS LOST AND THE PROCEDURE WAS CONSIDERED COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25367141 ↗
• MalfunctionMay 13, 2026Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD COIL, RUBY COIL, POD XL COIL (POD XL), A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA DIAGNOSTIC CATHETER. IT WAS NOTED THAT THE TARGET VESSEL WAS LOCATED ON A BEND WITHIN THE SPLENIC ARTERY. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE POD COIL AND ONE RUBY COIL IN THE TARGET VESSEL. WHILE ADVANCING A POD XL OUT OF THE DIAGNOSTIC CATHETER, RESISTANCE WAS FELT. THE EMBOLIZATION COIL WOULD NOT FORM WITHIN THE VESSEL. WHILE TORQUING THE 5FR DIAGNOSTIC CATHETER AND THE POD XL, THE PHYSICIAN NOTICED THE POD XL WAS NOT RESPONDING TO MOVEMENT. THE EMBOLIZATION COIL FRACTURED BUT WAS STILL CONNECTED TO IT¿S PUSHER ASSEMBLY. MAJORITY OF THE COIL REMAINED WITHIN THE 5F CATHETER. IT WAS REPORTED THAT THE ENTIRE POD XL WAS REMOVED FROM THE PATIENT BY HAND. THE PROCEDURE WAS COMPLETED WITH A NEW POD XL AND THE SAME DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25160940 ↗
• MalfunctionMay 13, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT GASTRIC VARICES USING A PACKING COIL XL, A NON-PENUMBRA CATHETER. WHILE ADVANCING A PACKING COIL XL THROUGH THE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE PUSHING THROUGH THE RESISTANCE, THE PACKING COIL XL PUSHER ASSEMBLY KINKED THEN FRACTURED. THIS CAUSED THE EMBOLIZATION COIL TO DETACH PARTIALLY WITHIN THE CATHETER AND THE TARGET VESSEL. THE PHYSICIAN ADVANCED A GUIDEWIRE (.035) TO PUSH THE REMAINING DETACHED EMBOLIZATION COIL INTO THE TARGET LOCATION. AFTER RETRACTING THE CATHETER, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE TAIL END OF THE PACKING COIL XL WAS FLOWING INTO THE SPLENIC VEIN. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE EMBOLIZATION COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH PACKING COILS AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159347 ↗
• MalfunctionApr 29, 2026Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING A PACKING COIL XL AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PACKING COIL XL INTO THE TARGET ARTERY. WHILE MANIPULATING THE PACKING COIL XL FOR PLACEMENT, THE COIL APPEARED TO DETACH FROM THE PUSHER ASSEMBLY. UPON REMOVAL OF THE PUSHER ASSEMBLY, IT WAS NOTICED THAT THE PACKING COIL XL REMAINED ATTACHED, AND THE COIL BEGAN TO UNRAVEL. IT WAS REPORTED THAT THE PACKING COIL XL WAS REMOVED FROM THE PATIENT IN ITS ENTIRETY. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL 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 25035441 ↗
• MalfunctionApr 29, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A LARGE GASTRIC VARICES FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) USING A PACKING COIL XL AND A NON-PENUMBRA CATHETER. AFTER ADVANCING A PACKING COIL XL INTO THE TARGET LOCATION, THE PHYSICIAN DECIDED TO RETRACT IT TO REPOSITION THE EMBOLIZATION COIL. WHILE RETRACTING THE PUSHER ASSEMBLY, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PACKING COIL XL HAD UNINTENTIONALLY DETACHED WITHIN THE CATHETER. THEREFORE, THE CATHETER CONTAINING THE DETACHED PACKING COIL XL WAS REMOVED AND THE EMBOLIZATION COIL WAS FLUSHED OUT. THE PHYSICIAN REGAINED ACCESS TO THE VESSEL USING THE SAME CATHETER. THE PROCEDURE WAS COMPLETED USING NEW RUBY XLS 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 25026741 ↗
• MalfunctionApr 16, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A NON-PENUMBRA SHEATH (7F X 45CM), A NON-PENUMBRA CATHETER (4F X 135CM), AND A GLIDEWIRE. WHILE ADVANCING A POD XL THROUGH THE CATHETER, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER AFTER ADVANCING MORE THAN HALFWAY. THE DETACHED EMBOLIZATION COIL WAS PUSHED INTO THE TARGET LOCATION USING THE GLIDEWIRE. FIVE NON-PENUMBRA COILS WERE THEN PLACED INTO THE TARGET VESSEL. THE PHYSICIAN DECIDED TO USE A PACKING COIL XL. WHILE ADVANCING THE PACKING COIL XL THROUGH THE CATHETER, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER AFTER ADVANCING APPROXIMATELY HALFWAY. THE DETACHED EMBOLIZATION COIL WAS PUSHED OUT OF THE CATHETER USING THE GLIDEWIRE, PROXIMAL TO THE TARGET VESSEL. IT WAS REPORTED THAT THE CATHETER WAS FLUSHED BETWEEN COIL PLACEMENT. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS 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 24894702 ↗
• MalfunctionApr 16, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A NON-PENUMBRA SHEATH (7F X 45CM), A NON-PENUMBRA CATHETER (4F X 135CM), AND A GLIDEWIRE. WHILE ADVANCING A POD XL THROUGH THE CATHETER, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER AFTER ADVANCING MORE THAN HALFWAY. THE DETACHED EMBOLIZATION COIL WAS PUSHED INTO THE TARGET LOCATION USING THE GLIDEWIRE. FIVE NON-PENUMBRA COILS WERE THEN PLACED INTO THE TARGET VESSEL. THE PHYSICIAN DECIDED TO USE A PACKING COIL XL. WHILE ADVANCING THE PACKING COIL XL THROUGH THE CATHETER, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER AFTER ADVANCING APPROXIMATELY HALFWAY. THE DETACHED EMBOLIZATION COIL WAS PUSHED OUT OF THE CATHETER USING THE GLIDEWIRE, PROXIMAL TO THE TARGET VESSEL. IT WAS REPORTED THAT THE CATHETER WAS FLUSHED BETWEEN COIL PLACEMENT. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS 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 24894687 ↗
• MalfunctionMar 26, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC ARTERY USING A POD XL COIL (POD XL), A NON-PENUMBRA CATHETER, A NON-PENUMBRA SHEATH (6FR) AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN OBTAINED ACCESS FROM THE LEFT GROIN AND ADVANCED THE GUIDEWIRE AND CATHETER THROUGH THE SHEATH. WHILE ATTEMPTING TO ADVANCE THE POD XL, THE PHYSICIAN REPORTED DIFFICULTY ADVANCING THE POD XL DUE TO VESSEL TORTUOSITY AND THE TURN FROM THE AORTA INTO THE TARGET ARTERY. UNDER FLUOROSCOPY, THE PHYSICIAN NOTICED THAT THE POD XL HAD UNINTENTIONALLY DETACHED, WITH A SMALL PART OF THE COIL REMAINING WITHIN THE CATHETER. WHILE ATTEMPTING TO REMOVE THE CATHETER, SOME PART OF THE COIL WAS PULLED INTO THE AORTA. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE POD XL. AFTER THE POD XL WAS REMOVED, THE PHYSICIAN PROCEEDED BY DOWNSIZING TO A RUBY COIL, AND PACKING COILS USING A LANTERN DELIVERY MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702169 ↗
• MalfunctionMar 20, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GONADAL VEIN USING RUBY COILS, RUBY COIL XLS, A PACKING COIL XL, AND A NON-PENUMBRA CATHETER. THE PHYSICIAN PLACED RUBY COILS AND RUBY COIL XLS IN THE TARGET LOCATION. THE CATHETER WAS THEN FLUSHED. WHILE ADVANCING A PACKING COIL XL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE EMBOLIZATION COIL WOULD NOT FORM AND PACK IN THE VESSEL. AFTER MAKING SEVERAL ATTEMPTS TO ADVANCE AND FORM THE COIL IN THE VESSEL, THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL XL. WHILE RETRACTING THE PACKING COIL XL, THE EMBOLIZATION COIL HAD UNINTENTIONALLY DETACHED WITHIN THE CATHETER WITH THE DISTAL END OF THE COIL STICKING OUT INTO THE VESSEL. THE CATHETER CONTAINING THE DETACHED PACKING COIL XL WAS REMOVED AND THE COIL WAS FLUSHED OUT FROM THE CATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COIL XLS, A POD XL, 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 24650989 ↗
• MalfunctionMar 16, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC VEIN USING A RUBY XL AND A NON-PENUMBRA ANGIOGRAPHIC CATHETER. DURING THE PROCEDURE, WHILE ADVANCING A RUBY XL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE RUBY XL HAD UNINTENTIONALLY DETACHED WITHIN THE ANGIOGRAPHIC CATHETER. THE PHYSICIAN REMOVED THE PUSHER ASSEMBLY AND THEN USED A GUIDEWIRE TO PUSH THE DETACHED RUBY XL INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY XLS AND THE SAME ANGIOGRAPHIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603678 ↗
• MalfunctionMar 11, 2026Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A COLLATERAL VESSEL USING A PACKING COIL XL, POD PACKING COILS (PACKING COILS), AND A NON-PENUMBRA CATHETER (4F). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL XL INTO THE VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE RETRACTING THE PACKING COIL XL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER. THE CATHETER CONTAINING THE EMBOLIZATION COIL WAS REMOVED. THE PHYSICIAN OPENED A LANTERN DELIVERY MICROCATHETER (LANTERN) AND ADVANCED A PACKING COIL INTO THE TARGET VESSEL. WHILE REPOSITIONING THE PACKING COIL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE VESSEL. A SNARE DEVICE WAS USED TO REMOVE THE DETACHED EMBOLIZATION COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW PACKING COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574542 ↗

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