PODRecalls & reported problems across all models
Penumbra, Inc. · 24 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,947
- Deaths reported
- 1
- Injuries reported
- 80
- Recalls
- 0
We found 24 models of POD by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 1,947 adverse event reports in the FDA's MAUDE database, received between Aug 14, 2015 and Sep 10, 2026 — classified as 1 death, 80 injuries, 1,866 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (820 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
Reports received per month, all models
Most reported POD problems
Device problems
- Physical Resistance/Sticking820
- Premature Separation606
- Failure to Advance530
- Material Deformation232
- Physical Resistance232
- Detachment Of Device Component114
- Failure to Fold99
- Break74
Patient problems
- No Consequences Or Impact To Patient1,159
- No Clinical Signs, Symptoms or Conditions817
- No Patient Involvement86
- No Known Impact Or Consequence To Patient16
- Foreign Body In Patient10
- Vasoconstriction7
- Device Embedded In Tissue or Plaque6
- No Information3
POD models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- POD RBYPODJ60-ADEVICE, NEUROVASCULAR EMBOLIZATION355 reports
- POD RBYPOD8-ADevice, Vascular, For Promoting Embolization195 reports
- POD RBYPOD6-ADEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-ADEVICE, NEUROVASCULAR EMBOLIZATION132 reports
- POD RBYPODJ60DEVICE, NEUROVASCULAR EMBOLIZATION131 reports
- POD RBYPODJ45-ADEVICE, NEUROVASCULAR EMBOLIZATION125 reports
- POD RBYPOD4DEVICE, NEUROVASCULAR EMBOLIZATION120 reports
- POD RBYPOD6DEVICE, NEUROVASCULAR EMBOLIZATION111 reports
- POD RBYPODJ15-ADEVICE, NEUROVASCULAR EMBOLIZATION96 reports
- POD RBYPOD8DEVICE, NEUROVASCULAR EMBOLIZATION90 reports
- POD RBYPOD10-ADevice, Vascular, For Promoting Embolization71 reports
- POD RBYPODJ30DEVICE, NEUROVASCULAR EMBOLIZATION58 reports
- POD RBYPODJ45DEVICE, NEUROVASCULAR EMBOLIZATION57 reports
- POD RBYPOD4-ADEVICE, NEUROVASCULAR EMBOLIZATION50 reports
- POD RBYPOD5DEVICE, NEUROVASCULAR EMBOLIZATION46 reports
- POD RBYPOD5-ADevice, Vascular, For Promoting Embolization35 reports
- POD RBYPODJ5-ADevice, Vascular, For Promoting Embolization34 reports
- POD RBYPODJ15DEVICE, NEUROVASCULAR EMBOLIZATION32 reports
- POD RBYPOD3-ADevice, Vascular, For Promoting Embolization21 reports
- POD RBYPOD12-ADevice, Vascular, For Promoting Embolization21 reports
- POD RBYPOD14-ADevice, Vascular, For Promoting Embolization1 death14 reports
- POD 400POD4-ADEVICE, NEUROVASCULAR EMBOLIZATION3 reports
- POD 400POD3-ADevice, Vascular, For Promoting Embolization1 report
- POD 400POD6-ADEVICE, NEUROVASCULAR EMBOLIZATION1 report
Recent POD adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionSep 10, 2026Premature Separation
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (GDA) using a POD Packing Coil (Packing Coil) and a Lantern Delivery Microcatheter (Lantern). It was reported that the Lantern was flushed prior to using the Packing Coil. Resistance was experienced while advancing the Packing Coil. The physician decided to retract the coil. While retracting the Packing Coil, the Packing Coil unintentionally detached within the Lantern. The Lantern containing the detached embolization coil was removed.The procedure was completed using another 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 50716056 ↗MalfunctionSep 9, 2026Premature Separation
The patient was undergoing a coil embolization procedure in the splenic artery using a POD Packing Coil (Packing Coil) and a non-Penumbra microcatheter. While advancing the Packing Coil through the microcatheter, the physician observed that the Packing Coil had unintentionally detached within the microcatheter. Consequently, the microcatheter containing the detached Packing Coil was removed from the patient.The procedure was completed using a new Packing Coil. There was no report of an adverse effect to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694180 ↗MalfunctionAug 26, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50461544 ↗MalfunctionJun 24, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERALS USING A POD PACKING COIL (PACKING COIL) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING A PACKING COIL INTO THE TARGET LOCATION USING THE LANTERN, THE LANTERN KICKED OUT OF THE VESSEL. THE PHYSICIAN WAS UNABLE TO ADVANCE THE LANTERN BACK INTO THE VESSEL. THE PHYSICIAN STILL ATTEMPTED TO ADVANCE THE PACKING COIL INTO THE VESSEL BUT NOTICED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE COIL WAS STUCK ON AN EXISTING VASCULAR PLUG. THE PHYSICIAN DECIDED TO REMOVE THE LANTERN AND PACKING COIL. WHILE RETRACTING THE PACKING COIL INTO THE LANTERN, THE PHYSICIAN WAS EXPERIENCING RESISTANCE, AND THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE AND FORCEPS TO REMOVE THE DETACHED PACKING COIL. THE PROCEDURE WAS COMPLETED USING A NEW PUSHABLE 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 25606522 ↗MalfunctionJun 24, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD PACKING COILS (PACKING COIL), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN SUCCESSFULLY PLACED NON-PENUMBRA COILS AND PACKING COILS INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT PACKING COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND DECIDED TO RETRACT THE PACKING COIL. WHILE RETRACTING THE PACKING COIL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE AFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25606422 ↗MalfunctionJun 12, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A POD PACKING COIL (PACKING COIL), AND A NON-PENUMBRA CATHETER. THE PHYSICIAN SUCCESSFULLY PLACED TWO NON-PENUMBRA COILS AT THE TARGET LOCATION. THE PHYSICIAN CONTINUED TO ADVANCE THE PACKING COIL DESPITE RESISTANCE, DURING WHICH THE MICROCATHETER REPEATEDLY KICKED BACK, FOLLOWED BY UNINTENTIONAL DETACHMENT OF THE PACKING COIL. A SNARE DEVICE WAS USED TO REMOVE THE DETACHED EMBOLIZATION COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL RUBY COILS, NON-PENUMBRA 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 25487915 ↗MalfunctionMay 22, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A POD PACKING COIL (PACKING COIL) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. WHILE ADVANCING THE PACKING COIL TO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MID-SHAFT OF THE MICROCATHETER. UPON ATTEMPTING TO RETRACT THE PACKING COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING FOUR NEW PACKING 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 25260796 ↗MalfunctionMay 21, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), A GUIDE CATHETER (038), AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. THE PHYSICIAN ADVANCED THE LANTERN AND GUIDE CATHETER TO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE A POD COIL, THE HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE POD COIL. AFTER RETRACTING THE COIL'S PUSHER ASSEMBLY, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE EMBOLIZATION COIL DETACHED WITHIN THE MID-SHAFT OF THE LANTERN. THE PHYSICIAN USED A SYRINGE TO ASPIRATE THE DETACHED EMBOLIZATION COIL OUT OF THE LANTERN. THE PHYSICIAN DECIDED TO OPEN A NEW POD COIL. WHILE REMOVING THE COIL FROM ITS PACKAGING HOOP, THE POD COIL PUSHER ASSEMBLY WAS NOTICED TO BE KINKED. THE POD COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NEW POD COIL AND THE SAME GUIDE CATHETER AND LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25240106 ↗MalfunctionApr 23, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A POD PACKING COIL (PACKING COIL), A GUIDING CATHETER, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE GUIDING CATHETER TO THE ORIGIN OF THE IIA, THEN ADVANCED THE LANTERN THROUGH THE GUIDING CATHETER TO THE TARGET LOCATION. WHILE ADVANCING THE PACKING COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE PACKING COIL WAS REMOVED FROM THE PATIENT AND THE DETACHED COIL WAS FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24968688 ↗MalfunctionApr 22, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. WHILE RETRACTING A POD COIL FOR RE-POSITIONING IN THE TARGET VESSEL, THE COIL UNINTENTIONALLY DETACHED IN AN UNWANTED PART OF THE SPLENIC ARTERY. HOWEVER, THE PHYSICIAN DECIDED IT WAS NOT NECESSARY TO RETRIEVE THE POD COIL. THE PROCEDURE WAS COMPLETED USING NON-PENUMBRA COILS AND THE SAME MICROCATHETER.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 24958705 ↗MalfunctionApr 22, 2026Material Deformation; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE POD COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER. DESPITE THE RESISTANCE, THE PHYSICIAN CONTINUED ADVANCING THE POD COIL, WHICH RESULTED IN A KINK AND SUBSEQUENT FRACTURE OF THE PUSHER ASSEMBLY. THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL AND A NEW MICROCATHETER (UNKNOWN). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953251 ↗MalfunctionApr 9, 2026Physical Resistance/Sticking; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY USING A POD COIL, POD PACKING COILS, A NON-PENUMBRA MICROCATHETER, AND A GUIDING CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE POD COIL AND THREE PACKING COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING AN ADDITIONAL PACKING COIL THROUGH THE INTRODUCER SHEATH AND INTO THE PROXIMAL PORTION OF THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. WHEN ATTEMPTING TO RETRACT THE PACKING COIL, IT WAS DETERMINED THAT THE COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS SUBSEQUENTLY REMOVED FROM THE PATIENT. FOLLOW-UP ANGIOGRAPHY PERFORMED THROUGH THE GUIDING CATHETER DEMONSTRATED THAT EMBOLIZATION HAD BEEN ACHIEVED TO SOME EXTENT; THEREFORE, THE PROCEDURE WAS CONCLUDED AT THAT TIME. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832096 ↗MalfunctionApr 9, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD PACKING COILS (PACKING COILS), A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA COIL, AND A 5F CATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. THE PHYSICIAN PLACED THE NON-PENUMBRA COIL AND FOUR PACKING COILS INTO THE TARGET VESSEL USING THE LANTERN AND THE 5F CATHETER. WHILE ATTEMPTING TO REPOSITION ANOTHER PACKING COIL MULTIPLE TIMES, THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED PACKING COIL WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT OF THE LANTERN ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING NEW PACKING COILS, THE SAME LANTERN, AND THE SAME 5F CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832027 ↗MalfunctionApr 9, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING POD PACKING COILS (PACKING COILS), NON-PENUMBRA COILS, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NON-PENUMBRA COILS AND A PACKING COIL INTO THE TARGET LOCATION. WHILE ATTEMPTING TO IMPLANT ANOTHER PACKING COIL, THE COIL WENT IN AN UNWANTED DIRECTION. THE PHYSICIAN WAS RETRACTING THE PACKING COIL TO RE-POSITION IT WHEN THE COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE SHEATH AND PARTIALLY WITHIN THE PATIENT. THE PHYSICIAN THEN USED ANOTHER NON-PENUMBRA SHEATH THROUGH A SECOND ACCESS POINT AND USED FORCEPS TO REMOVE THE DETACHED PACKING COIL. AT THIS POINT, 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 24831436 ↗
Other Penumbra, Inc. products
- RUBY Coil90 models · 2,838 reports
- Smart Coil98 models · 2,616 reports
- Penumbra System59 models · 2,164 reports · 4 recalls
- Indigo System64 models · 1,873 reports
- Penumbra Coil 400120 models · 842 reports
- Lantern Delivery Catheter11 models · 817 reports
- LP Coil System38 models · 725 reports
- Neuron36 models · 517 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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