RUBY CoilRecalls & reported problems across all models
Penumbra, Inc. · 90 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,838
- Deaths reported
- 2
- Injuries reported
- 118
- Recalls
- 0
We found 90 models of RUBY Coil by Penumbra, Inc. in the FDA's device registry (GUDID). Together they are named in 2,838 adverse event reports in the FDA's MAUDE database, received between Aug 12, 2015 and Sep 29, 2026 — classified as 2 deaths, 118 injuries, 2,718 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (1,011 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 RUBY Coil problems
Device problems
- Failure to Advance1,011
- Physical Resistance689
- Physical Resistance/Sticking602
- Premature Separation418
- Detachment Of Device Component405
- Kinked237
- Material Deformation197
- Device Handling Problem173
Patient problems
- No Consequences Or Impact To Patient2,054
- No Clinical Signs, Symptoms or Conditions519
- No Patient Involvement245
- No Known Impact Or Consequence To Patient131
- Device Embedded In Tissue or Plaque9
- Foreign Body In Patient9
- Thrombus3
- Injury2
RUBY Coil models
90 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RUBY Coil RBY4C0860-ADEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- RUBY Coil RBY2C1260-ADEVICE, NEUROVASCULAR EMBOLIZATION103 reports
- RUBY Coil RBY2C3260-ADEVICE, NEUROVASCULAR EMBOLIZATION100 reports
- RUBY Coil RBY2C1035-ADEVICE, NEUROVASCULAR EMBOLIZATION97 reports
- RUBY Coil RBY2C1460-ADEVICE, NEUROVASCULAR EMBOLIZATION89 reports
- RUBY Coil RBY2C2060-ADEVICE, NEUROVASCULAR EMBOLIZATION86 reports
- RUBY Coil RBY4C0315-ADEVICE, NEUROVASCULAR EMBOLIZATION79 reports
- RUBY Coil RBY4C0630-ADEVICE, NEUROVASCULAR EMBOLIZATION1 death79 reports
- RUBY Coil RBY4C2060-ADEVICE, NEUROVASCULAR EMBOLIZATION79 reports
- RUBY Coil RBY2C1660-ADEVICE, NEUROVASCULAR EMBOLIZATION67 reports
- RUBY Coil RBY2C2457-ADEVICE, NEUROVASCULAR EMBOLIZATION67 reports
- RUBY Coil RBY2C0435-ADEVICE, NEUROVASCULAR EMBOLIZATION64 reports
- RUBY Coil RBY2C0320-ADEVICE, NEUROVASCULAR EMBOLIZATION63 reports
- RUBY Coil RBY4C0860-BDevice, Vascular, For Promoting Embolization56 reports
- RUBY Coil RBY4C0415-ADEVICE, NEUROVASCULAR EMBOLIZATION51 reports
- RUBY Coil RBY4C0315-BDevice, Vascular, For Promoting Embolization49 reports
- RUBY Coil RBY4C0204-ADEVICE, NEUROVASCULAR EMBOLIZATION49 reports
- RUBY Coil RBY4C1650-ADEVICE, NEUROVASCULAR EMBOLIZATION49 reports
- RUBY Coil RBY2C0530-ADEVICE, NEUROVASCULAR EMBOLIZATION48 reports
- RUBY Coil RBY2C1857-ADEVICE, NEUROVASCULAR EMBOLIZATION47 reports
- RUBY Coil RBY2C2860-ADEVICE, NEUROVASCULAR EMBOLIZATION46 reports
- RUBY Coil RBY4C0835-ADEVICE, NEUROVASCULAR EMBOLIZATION46 reports
- RUBY Coil RBY2C0840-ADEVICE, NEUROVASCULAR EMBOLIZATION44 reports
- RUBY Coil RBY2C1260-BDevice, Vascular, For Promoting Embolization42 reports
- RUBY Coil RBY4C0415-BDevice, Vascular, For Promoting Embolization41 reports
- RUBY Coil RBY4C0202-ADEVICE, NEUROVASCULAR EMBOLIZATION40 reports
- RUBY Coil RBY2C0630-ADEVICE, NEUROVASCULAR EMBOLIZATION39 reports
- RUBY Coil RBY4C0620-ADEVICE, NEUROVASCULAR EMBOLIZATION39 reports
- RUBY Coil RBY2C0430-ADEVICE, NEUROVASCULAR EMBOLIZATION35 reports
- RUBY Coil RBY2C1240-ADEVICE, NEUROVASCULAR EMBOLIZATION1 death35 reports
- RUBY Coil RBY4C0204-BDevice, Vascular, For Promoting Embolization34 reports
- RUBY Coil RBY2C0312-ADEVICE, NEUROVASCULAR EMBOLIZATION32 reports
- RUBY Coil RBY2C0420-ADEVICE, NEUROVASCULAR EMBOLIZATION32 reports
- RUBY Coil RBY4C0835-BDevice, Vascular, For Promoting Embolization31 reports
- RUBY Coil RBY2C0825-ADEVICE, NEUROVASCULAR EMBOLIZATION30 reports
- RUBY Coil RBY4C0630-BDevice, Vascular, For Promoting Embolization29 reports
- RUBY Coil RBY4C0305-ADEVICE, NEUROVASCULAR EMBOLIZATION29 reports
- RUBY Coil RBY4C0305-BDevice, Vascular, For Promoting Embolization26 reports
- RUBY Coil RBY4C0406-ADEVICE, NEUROVASCULAR EMBOLIZATION25 reports
- RUBY Coil RBY2C2457-BDevice, Vascular, For Promoting Embolization23 reports
- RUBY Coil RBY2C0520-ADEVICE, NEUROVASCULAR EMBOLIZATION22 reports
- RUBY Coil RBY2C0930-ADEVICE, NEUROVASCULAR EMBOLIZATION22 reports
- RUBY Coil RBY4C0202-BDevice, Vascular, For Promoting Embolization21 reports
- RUBY Coil RBY2C0620-ADEVICE, NEUROVASCULAR EMBOLIZATION20 reports
- RUBY Coil RBY4C1035-BDevice, Vascular, For Promoting Embolization19 reports
- RUBY Coil RBY2C1660-BDevice, Vascular, For Promoting Embolization19 reports
- RUBY Coil RBY4C0201-ADEVICE, NEUROVASCULAR EMBOLIZATION18 reports
- RUBY Coil RBY2C1460-BDevice, Vascular, For Promoting Embolization17 reports
- RUBY Coil RBY2C3260-BDevice, Vascular, For Promoting Embolization17 reports
- RUBY Coil RBY2C0305-ADEVICE, NEUROVASCULAR EMBOLIZATION17 reports
- RUBY Coil RBY2C1035-BDevice, Vascular, For Promoting Embolization16 reports
- RUBY Coil RBY2C1857-BDevice, Vascular, For Promoting Embolization16 reports
- RUBY Coil RBY2C2860-BDevice, Vascular, For Promoting Embolization16 reports
- RUBY Coil RBY2C4060-BDevice, Vascular, For Promoting Embolization16 reports
- RUBY Coil RBY2C0415-ADEVICE, NEUROVASCULAR EMBOLIZATION16 reports
- RUBY Coil RBY2C0725-ADEVICE, NEUROVASCULAR EMBOLIZATION16 reports
- RUBY Coil RBY4C0406-BDevice, Vascular, For Promoting Embolization15 reports
- RUBY Coil RBY2C0530-BDevice, Vascular, For Promoting Embolization15 reports
- RUBY Coil RBY2C0410-ADEVICE, NEUROVASCULAR EMBOLIZATION15 reports
- RUBY Coil RBY4C1240-ADEVICE, NEUROVASCULAR EMBOLIZATION15 reports
- RUBY Coil RBY2C0512-ADEVICE, NEUROVASCULAR EMBOLIZATION14 reports
- RUBY Coil RBY2C0312-BDevice, Vascular, For Promoting Embolization13 reports
- RUBY Coil RBY2C0305-BDevice, Vascular, For Promoting Embolization12 reports
- RUBY Coil RBY2C0320-BDevice, Vascular, For Promoting Embolization12 reports
- RUBY Coil RBY2C0840-BDevice, Vascular, For Promoting Embolization11 reports
- RUBY Coil RBY4C0620-BDevice, Vascular, For Promoting Embolization10 reports
- RUBY Coil RBY2C0630-BDevice, Vascular, For Promoting Embolization10 reports
- RUBY Coil RBY2C3660-BDevice, Vascular, For Promoting Embolization10 reports
- RUBY Coil RBY2C0410-BDevice, Vascular, For Promoting Embolization9 reports
- RUBY Coil RBY2C0740-ADEVICE, NEUROVASCULAR EMBOLIZATION9 reports
- RUBY Coil RBY2C0620-BDevice, Vascular, For Promoting Embolization8 reports
- RUBY Coil RBY2C0825-BDevice, Vascular, For Promoting Embolization8 reports
- RUBY Coil RBY2C0435-BDevice, Vascular, For Promoting Embolization7 reports
- RUBY Coil RBY2C1240-BDevice, Vascular, For Promoting Embolization7 reports
- RUBY Coil RBY2C1440-ADEVICE, NEUROVASCULAR EMBOLIZATION6 reports
- RUBY Coil RBY4C0201-BDevice, Vascular, For Promoting Embolization5 reports
- RUBY Coil RBY2C0420-BDevice, Vascular, For Promoting Embolization5 reports
- RUBY Coil RBY2C0512-BDevice, Vascular, For Promoting Embolization5 reports
- RUBY Coil RBY4C2060-BDevice, Vascular, For Promoting Embolization5 reports
- RUBY Coil RBY2C0612-ADEVICE, NEUROVASCULAR EMBOLIZATION5 reports
- RUBY Coil RBY4C1035-ADEVICE, NEUROVASCULAR EMBOLIZATION5 reports
- RUBY Coil RBY2C0725-BDevice, Vascular, For Promoting Embolization4 reports
- RUBY Coil RBY2C0430-BDevice, Vascular, For Promoting Embolization3 reports
- RUBY Coil RBY4C1650-BDevice, Vascular, For Promoting Embolization3 reports
- RUBY Coil RBY2C0520-BDevice, Vascular, For Promoting Embolization2 reports
- RUBY Coil RBY4C1240-BDevice, Vascular, For Promoting Embolization2 reports
- RUBY Coil RBY2C0415-BDevice, Vascular, For Promoting Embolization1 report
- RUBY Coil RBY2C0740-BDevice, Vascular, For Promoting Embolization1 report
- RUBY Coil RBY2C0930-BDevice, Vascular, For Promoting Embolization1 report
- RUBY Coil RBY2C1440-BDevice, Vascular, For Promoting Embolization1 report
Recent RUBY Coil adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937684 ↗MalfunctionSep 29, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936955 ↗MalfunctionSep 23, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876177 ↗MalfunctionSep 15, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50776846 ↗MalfunctionSep 10, 2026Premature Separation
The patient was undergoing a coil embolization procedure in the aortic false lumen using a Ruby Coil, and a Lantern Delivery Microcatheter (Lantern). The Ruby Coil would not advance beyond a certain point within the Lantern. Therefore, the physician attempted to retract the coil. While retracting the coil back, the Ruby Coil unintentionally detached within the microcatheter. Therefore, the Lantern containing the detached the Ruby Coil was removed. The procedure was completed at this point. There was no report of an adverse effect to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50712638 ↗MalfunctionJun 25, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON HEPATIC ARTERY USING RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND AN ACCESS SHEATH. THE PHYSICIAN ADVANCED THE ACCESS SHEATH INTO THE COELIAC TRUNK FOLLOWED BY A STENT ACROSS THE NECK OF THE ANEURYSM. WHILE ADVANCING THE FOURTH RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE COIL WAS REMOVED FROM THE PATIENT UNDER ASPIRATION. ON THE BACK TABLE, THE PHYSICIAN PULLED THE COIL OUT OF THE MICROCATHETER, WHICH RESULTED IN THE COIL TO UNRAVEL. A NEW MICROCATHETER OF THE SAME TYPE WAS THEN INTRODUCED TO THE PATIENT AND A DIAGNOSTIC CATHETER WAS USED AS SUPPORT. FOUR ADDITIONAL COILS WERE THEN IMPLANTED IN THE TARGET LOCATION. WHILE ADVANCING THE FINAL RUBY COIL, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN THEN USED A GUIDEWIRE TO PUSH THE DETACHED RUBY COIL INTO THE TARGET LOCATION AND REMOVED THE MICROCATHETER. THE PHYSICIAN BEGAN TO REMOVE THE DIAGNOSTIC CATHETER AND OBSERVED THAT THE PROXIMAL END OF THE RUBY COIL MOVED WHEN THE DIAGNOSTIC CATHETER WAS RETRACTED. TH
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25627490 ↗MalfunctionJun 12, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. THE PHYSICIAN SUCCESSFULLY PLACED THREE RUBY COILS IN THE TARGET LOCATION USING THE MICROCATHETER. AFTER ADVANCING ANOTHER RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN REPORTED THAT THE COIL WAS NOT TAKING ITS INTENDED SHAPE. WHILE REPEATEDLY ADVANCING AND RETRACTING THE RUBY COIL, THE COIL UNINTENTIONALLY DETACHED. THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT, AND THE COIL WAS FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A TOTAL OF FIFTEEN RUBY COILS AND POD 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 25490131 ↗MalfunctionMay 27, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN SPLENIC ARTERY USING A RUBY COIL, A NON-PENUMBRA DIAGNOSTIC CATHETER AND A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE THE RUBY COIL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THAT THE RUBY COIL WOULD NOT ADVANCE. THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. WHILE RETRACTING THE RUBY COIL, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE DIAGNOSTIC CATHETER AND THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING SEVEN ADDITIONAL RUBY COILS, ANOTHER MICROCATHETER, AND ANOTHER DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25306918 ↗MalfunctionApr 22, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING RUBY COILS AND A MICROCATHETER. THE PHYSICIAN WAS ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER AND REPORTED THAT THE COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE VESSEL AND PARTIALLY WITHIN THE MICROCATHETER. THEREFORE, THE RUBY COIL AND MICROCATHETER WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL 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 24960939 ↗MalfunctionApr 10, 2026Failure to Fold; Premature Separation
THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE INVOLVING MULTIPLE VESSELS OF THE RIGHT INTERNAL ILIAC ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). ONE TARGET VESSEL WAS SUCCESSFULLY TREATED, AFTER WHICH THE LANTERN WAS REPOSITIONED. DURING ADVANCEMENT OF A RUBY COIL INTO THE SUBSEQUENT TARGET VESSEL, THE COIL DID NOT FORM AS INTENDED. THE PHYSICIAN ELECTED TO WITHDRAW THE COIL. DURING RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN MICROCATHETER. THE LANTERN CONTAINING THE DETACHED COIL WAS REMOVED FROM THE PATIENT, AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND A NEW LANTERN MICROCATHETER. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845311 ↗MalfunctionMar 26, 2026Material Deformation; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN PLACED ONE RUBY COIL IN THE TARGET LOCATION USING THE LANTERN. THE PHYSICIAN WAS THEN ADVANCING A NEW RUBY COIL THROUGH THE LANTERN AND KINKED THE PUSHER ASSEMBLY OF THE EMBOLIZATION COIL. UPON RETRACTING THE PUSHER ASSEMBLY, THE RUBY COIL HAD UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE USING A NEW POD COIL AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24708541 ↗MalfunctionFeb 2, 2026Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A RUBY COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24239349 ↗MalfunctionJan 12, 2026Physical Resistance/Sticking; Premature Separation
THE PATIENT WAS UNDERGOING A TIPS (TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT) PROCEDURE IN THE CORONAL VEIN VARICES USING A RUBY COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN BEGAN ADVANCING THE RUBY COIL THROUGH THE MICROCATHETER. THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN USED SALINE TO FLUSH THE DETACHED COIL INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24048652 ↗MalfunctionDec 5, 2025Premature Separation; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT LOBE OF THE LIVER USING A RUBY COIL, A NON-PENUMBRA MICROCATHETER, AND A DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE RUBY COIL WAS PARTIALLY PLACED IN THE TARGET LOCATION WHEN THE COIL UNINTENTIONALLY DETACHED. THE MICROCATHETER WAS RETRACTED SUCH THAT THE RUBY COIL WAS SITUATED INSIDE THE DIAGNOSTIC CATHETER. THE PHYSICIAN ATTEMPTED TO PUSH THE COIL OUT OF THE DIAGNOSTIC CATHETER USING A GUIDEWIRE, BUT WAS UNSUCCESSFUL. WHILE REMOVING THE DIAGNOSTIC CATHETER, THE RUBY COIL FRACTURED. THE PHYSICIAN WAS ABLE TO REMOVE MOST OF THE FRACTURED COIL FROM THE DIAGNOSTIC CATHETER BY HAND. THE REMAINING PORTION OF THE FRACTURED COIL WAS LEFT IN THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23726313 ↗MalfunctionDec 1, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CORONARY ARTERY USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE RUBY COILS IN THE TARGET LOCATION USING THE LANTERN. WHILE ADVANCING ANOTHER RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE MID-SHAFT OF THE LANTERN. WHILE ATTEMPTING TO RETRACT AND RE-ADVANCE THE RUBY COIL WITHIN THE LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED FROM THE PATIENT, AND THE RUBY COIL WAS THEN FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW RUBY 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 23687814 ↗
Other Penumbra, Inc. products
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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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