POD RBYPOD14-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00814548019673), received between Aug 17, 2018 and Sep 10, 2026 — classified as 1 death, 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50717051 ↗
• MalfunctionOct 15, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY, USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A POD COIL. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND CALCIFIED. WHILE ADVANCING THE POD COIL THROUGH THE PROXIMAL LENGTH OF THE LANTERN, THE POD COIL GOT STUCK. THEREFORE, THE POD COIL WAS REMOVED. THE PHYSICIAN THEN FLUSHED THE LANTERN AND ATTEMPTED TO ADVANCE THE POD COIL AGAIN; HOWEVER, IT GOT STUCK AND THE COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. IT WAS REPORTED THAT THE POD COIL WAS FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING NEW POD COILS, POD PACKING COILS (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 20450833 ↗
• MalfunctionMay 3, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA BASE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE LANTERN THROUGH THE NON-PENUMBRA BASE CATHETER TO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE A POD COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE POD COIL WOULD NOT EXIT THE DISTAL END OF THE LANTERN. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE POD COIL. WHILE RETRACTING THE POD COIL, THE PHYSICIAN MET RESISTANCE, AND THE POD COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. IT WAS REPORTED THAT THE NON-PENUMBRA BASE CATHETER WAS PINCHING INTO THE LANTERN ON ONE OF THE TURNS IN THE SPLENIC ARTERY THAT CAUSED THE MID-DISTAL PORTION OF THE LANTERN TO KINK. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING TWO NON-PENUMBRA COILS AND THE SAME NON-PENUMBRA BASE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243621 ↗
• MalfunctionJun 18, 2021Failure to Fold; Physical Resistance/Sticking; Failure to Fold; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A VARIX USING A POD COIL AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE POD COIL WAS NOT TAKING ITS INTENDED SHAPE IN THE TARGET LOCATION UPON INITIAL ADVANCEMENT; THEREFORE, THE POD COIL WAS RETRACTED BACK INTO ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE HOSPITAL TECHNOLOGIST WAS EXPERIENCING RESISTANCE WHILE ATTEMPTING TO ADVANCE THE SAME POD COIL INTO MICROCATHETER. AFTER MULTIPLE ATTEMPTS, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING RUBY COILS, POD PACKING COILS (POD PC), 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 12028192 ↗
• MalfunctionMar 29, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT HYPOGASTRIC ARTERY USING POD PACKING COILS (POD PCS), POD COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, A POD PC WAS ADVANCED INTO THE TARGET VESSEL AND SUBSEQUENTLY RETRACTED FOR RE-POSITIONING WHEN IT DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD PC WAS REMOVED FROM THE PATIENT AND THE POD PC WAS SUBSEQUENTLY REMOVED. WHILE ADVANCING A POD COIL PUSHER WIRE THROUGH ITS INTRODUCER SHEATH, THE PUSHER WIRE BECAME KINKED. THEREFORE, THE POD COIL WAS NO LONGER USED IN THE PROCEDURE. NEXT, THE SAME ISSUE OCCURRED WITH ANOTHER POD COIL; THEREFORE, THIS POD COIL WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL POD PCS AND POD COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586918 ↗
• InjuryDec 30, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT WAS TREATED FOR A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) AND RESULTED WITH THE FLOW THROUGH THE HUGE COIL MASS BEING NINETY-FIVE PERCENT STAGNANT. HOWEVER, ON (B)(6) 2020, THE PHYSICIAN REANALYZED THE PAVM AND DECIDED TO PLACE A POD COIL BEHIND THE EXISTING COIL MASS. DURING THE PROCEDURE, WHILE THE PHYSICIAN ATTEMPTED TO PLACE A POD COIL BEHIND THE COIL MASS, THE POD COIL UNINTENTIONALLY DETACHED WITH APPROXIMATELY FORTY CENTIMETERS OF THE POD COIL REMAINING OUTSIDE THE COIL MASS. THE PHYSICIAN THEN ATTEMPTED TO DRAW NEGATIVE PRESSURE ON THE LANTERN; HOWEVER, IT WAS UNSUCCESSFUL. THEN, THE PHYSICIAN ATTEMPTED TO DRAW NEGATIVE PRESSURE WHILE REMOVING THE LANTERN; HOWEVER, IT WAS ALSO UNSUCCESSFUL. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO USE A MICRO SNARE BUT WAS ALSO UNSUCCESSFUL. LASTLY, THE PHYSICIAN USED AN ENSNARE THROUGH THE NEURON MAX TO REMOVE THE POD COIL AND WAS SUCCESSFUL. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT. THERE WAS NO REPORT OF A

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

  MAUDE report 11094831 ↗
• MalfunctionOct 23, 2020Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL INTO THE LANTERN, THE PHYSICIAN NOTICED A KINK ON THE PUSHER ASSEMBLY APPROXIMATELY TEN CENTIMETERS FROM THE PROXIMAL END. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, SIX POD PACKING COILS (POD PCS), TWO NON-PENUMBRA COILS AND THE SAME LANTERN. 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 10731495 ↗
• MalfunctionSep 24, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE POD COIL THROUGH THE LANTERN. THE PHYSICIAN TRIED TO ADVANCE THE POD COIL THROUGH THE LANTERN AGAIN AND ENCOUNTERED MORE RESISTANCE. THEREFORE, THE LANTERN AND POD COIL WERE REMOVED TOGETHER FROM THE PATIENT. AFTER REMOVAL, WHILE THE DEVICES WERE ON THE BACK TABLE, THE PHYSICIAN REALIZED THE POD COIL HAD DETACHED INSIDE THE LANTERN. SUBSEQUENTLY, THE POD COIL WAS REMOVED FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, ANOTHER POD COIL, AND THREE NON-PENUMBRA COILS. 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 10580037 ↗
• MalfunctionMay 28, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE EXTERNAL ILIAC ARTERY USING POD COILS, RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO POD COILS AND ONE RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN. THE NEXT POD COIL WAS UNABLE TO ADVANCE MORE THAN SIX INCHES INTO THE LANTERN; THEREFORE, THE PHYSICIAN REMOVED THE LANTERN AND USED A NON-PENUMBRA MICROCATHETER INSTEAD. HOWEVER, THE POD COIL WAS UNABLE TO ADVANCE INTO THIS MICROCATHETER AND THE POD COIL WAS SUBSEQUENTLY REMOVED. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND A NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10098844 ↗
• MalfunctionFeb 4, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A POD14, NON-PENUMBRA CATHETER AND, LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS ALSO REPORTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND SLIGHTLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A POD14 THROUGH THE LANTERN AND, THEREFORE, IT WAS REMOVED. WHILE RETRACTING, THE POD14 UNINTENTIONALLY DETACHED INSIDE OF THE LANTERN AROUND THE HUB. THEREFORE, THE LANTERN WAS REMOVED CONTAINING THE DETACHED POD14. THE PROCEDURE WAS COMPLETED USING ANOTHER COIL, POD PACKING COILS (POD PCS) 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 9665201 ↗
• MalfunctionJun 6, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS AND POD14S. DURING THE PROCEDURE, THE PUSHER ASSEMBLY OF A RUBY COIL BECAME KINKED WHILE BEING REMOVED FROM THE PACKAGING HOOP. THE DAMAGE TO THE RUBY COIL OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING THE POD14 INTO THE LANTERN DELIVERY MICROCATHETER (LANTERN) AND, CONSEQUENTLY, THE POD14 UNINTENTIONALLY DETACHED. THE PHYSICIAN WAS ABLE TO PULL OUT THE POD14, AND THE PROCEDURE WAS THEN COMPLETED USING A POD12 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 8674906 ↗
• MalfunctionMar 26, 2019Material Deformation; Physical Resistance/Sticking; Separation Problem; Material Deformation; Physical Resistance/Sticking; Separation Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD14S. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A LANTERN DELIVERY MICROCATHETER (LANTERN) INTO THE TARGET VESSEL. THE PHYSICIAN THEN REPORTED FEELING RESISTANCE WHILE ADVANCING THE FIRST POD14 INTO THE LANTERN. THE POD14 PUSHER WIRE THEN BECAME KINKED AND THE COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE POD14 WAS THEN REMOVED FROM THE LANTERN AND WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING SEVEN NON-PENUMBRA 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 8453247 ↗
• DeathMar 1, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD14 AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A GUIDEWIRE INTO THE PROXIMAL PORTION OF THE TARGET VESSEL FOLLOWED BY A NON-PENUMBRA GUIDE CATHETER. THE PHYSICIAN THEN ADVANCED A NON-PENUMBRA MICROCATHETER OVER THE GUIDEWIRE INTO THE TARGET LOCATION, DISTAL TO THE PSEUDOANEURYSM, AND BEGAN EMBOLIZATION. WHILE ADVANCING A POD14 INTO THE TARGET VESSEL, THE POD14 UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE POD14 WAS UNABLE TO BE RETRIEVED FROM THE MICROCATHETER; THEREFORE, THE MICROCATHETER WAS REMOVED. THE POD14 REMAINED PARTIALLY IN THE GUIDE CATHETER AND PARTIALLY IN THE SPLENIC ARTERY BEYOND THE PSEUDOANEURYSM. THE POD14 WAS RETRIEVED FROM WITHIN THE GUIDING CATHETER USING A SNARE DEVICE AND WAS REMOVED INTACT. AFTER RE-ACCESSING THE TARGET VESSEL, THE PHYSICIAN PERFORMED ARTERIOGRAPHY DEMONSTRATING EXTRAVASATION OF CONTRAST ORIGINATING FROM A RUPTURED PROXIMAL SPLENIC ARTERIAL PSEUDOANEURYSM. THE PATIENT EXPERIENCED SIGNIFICANT BLOOD LOSS RESULTING IN PROFOUND HEMODYNAMIC INSTABILITY, AND HAD NO PULSE. CARDIAC LIFE SUPPORT AND MULTIPLE BLOOD TRANSFUSIONS WERE PERF

  Patient problems: Blood Loss; Cardiac Arrest; Death

  MAUDE report 8381057 ↗
• MalfunctionAug 17, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE POD14 WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE POD14 WAS FOUND PRIOR TO USE. THEREFORE, THE POD14 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW POD14.

  Patient problems: No Patient Involvement

  MAUDE report 7794075 ↗