LP Coil System RBYLP0406Recalls & reported problems
Penumbra, Inc. · Ruby Coil LP, 4 mm x 6 cm · Class 2 · Implant
All models of LP Coil System (38)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00815948021808), received between Sep 11, 2020 and May 15, 2023 — classified as 20 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (10 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
Device problems
- Failure to Advance10
- Separation Failure5
- Physical Resistance/Sticking3
- Difficult or Delayed Separation2
- Failure to Fold1
- Material Deformation1
- Material Twisted/Bent1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient7
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2023Difficult or Delayed Separation; Difficult or Delayed Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK IN THE LUMBAR ARTERY TO USING RUBY COIL LPS, AN LP DETACHMENT HANDLE SYSTEM, AND A MICROCATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH THE RUBY COIL LP WITH THE HANDLE; HOWEVER, THE RUBY COIL LP WOULD NOT DETACH. THEN, THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP WITHOUT SUCCESS. NEXT, WHILE RETRACTING THE RUBY COIL LP, THE RUBY COIL LP UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED SALINE INJECTION TO PUSH THE RUBY COIL LP INTO THE TARGET LOCATION AND USED THE PUSHER ASSEMBLY TO PACK THE RUBY COIL LP INTO POSITION. NEXT, THE SAME ISSUE OCCURRED WITH A SECOND RUBY COIL. THEREFORE, THE RUBY COIL LP WAS ALSO IMPLANTED INTO THE TARGET LOCATION USING SALINE INJECTION AND THE PUSHER ASSEMBLY TO PACK THE RUBY COIL LP INTO POSITION. 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 16928457 ↗MalfunctionNov 30, 2021Failure to Advance; Failure to Advance
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OFF THE OVARIAN VEIN USING RUBY COIL LPS. DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE AT ALL PAST THEIR INITIAL POSITIONS WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COIL LPS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12901456 ↗MalfunctionNov 11, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A RUBY COIL LP. DURING THE PROCEDURE, THE PUSHER ASSEMBLY OF THE RUBY COIL LP WAS STUCK AND WOULD NOT ADVANCE AT ALL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12800809 ↗MalfunctionOct 15, 2021Failure to Advance; Failure to Advance
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ARTERIOVENOUS (AV) FISTULA USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT RELEASE FROM THE STARTING POSITION OF THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW LP COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12641594 ↗MalfunctionSep 24, 2021Material Deformation; Material Deformation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COIL LPS AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT THE RUBY COIL LP INTO THE MICROCATHETER, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL LP. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP 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 12530496 ↗MalfunctionAug 31, 2021Separation Failure; Separation Failure
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) TO TREAT A TYPE II ENDOLEAK USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLES), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE RUBY COIL LP INTO THE ANEURYSM, THE RUBY COIL LP KICKED THE MICROCATHETER OUT OF THE TARGET VESSEL DUE TO THE RUBY COIL LP BEING BIG FOR THE SIZE OF THE ANEURYSM. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. WHILE ATTEMPTING TO RETRACT AND RECAPTURE THE RUBY COIL LP, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL LP AT MULTIPLE LOCATIONS. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING AND RETRACTING THE RUBY COIL LP DUE TO THE TORTUOUS ANATOMY OF THE PATIENT. NEXT, THE PHYSICIAN ADVANCED A SMALLER RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN MADE ADDITIONAL ATTEMPTS TO DETACH THE RUBY COIL LP USING A NEW HANDLE AND BY MANUALLY DETACHING IT BUT WERE UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12402564 ↗MalfunctionAug 31, 2021Separation Failure; Separation Failure
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) TO TREAT A TYPE II ENDOLEAK USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLES), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE RUBY COIL LP INTO THE ANEURYSM, THE RUBY COIL LP KICKED THE MICROCATHETER OUT OF THE TARGET VESSEL DUE TO THE RUBY COIL LP BEING BIG FOR THE SIZE OF THE ANEURYSM. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. WHILE ATTEMPTING TO RETRACT AND RECAPTURE THE RUBY COIL LP, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL LP AT MULTIPLE LOCATIONS. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING AND RETRACTING THE RUBY COIL LP DUE TO THE TORTUOUS ANATOMY OF THE PATIENT. NEXT, THE PHYSICIAN ADVANCED A SMALLER RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN MADE ADDITIONAL ATTEMPTS TO DETACH THE RUBY COIL LP USING A NEW HANDLE AND BY MANUALLY DETACHING IT BUT WERE UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12402562 ↗MalfunctionAug 31, 2021Difficult or Delayed Separation; Difficult or Delayed Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) TO TREAT A TYPE II ENDOLEAK USING RUBY COIL LPS, LP SYSTEM DETACHMENT HANDLES (HANDLES), AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE THE RUBY COIL LP INTO THE ANEURYSM, THE RUBY COIL LP KICKED THE MICROCATHETER OUT OF THE TARGET VESSEL DUE TO THE RUBY COIL LP BEING BIG FOR THE SIZE OF THE ANEURYSM. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL LP. WHILE ATTEMPTING TO RETRACT AND RECAPTURE THE RUBY COIL LP, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL LP AT MULTIPLE LOCATIONS. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING AND RETRACTING THE RUBY COIL LP DUE TO THE TORTUOUS ANATOMY OF THE PATIENT. NEXT, THE PHYSICIAN ADVANCED A SMALLER RUBY COIL LP INTO THE TARGET VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THE PHYSICIAN THEN MADE ADDITIONAL ATTEMPTS TO DETACH THE RUBY COIL LP USING A NEW HANDLE AND BY MANUALLY DETACHING IT BUT WERE UNSUCCESSFUL. THEREFORE, THE RUBY COIL LP WAS REMOVED. SUBSEQUENTLY,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12402359 ↗MalfunctionAug 13, 2021Failure to Advance; Failure to Advance
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT GASTROINTESTINAL (GI) BLEEDING USING RUBY COILS, RUBY COIL LPS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE OUT OF THE INTRODUCER SHEATHS. THEREFORE, THE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12321953 ↗MalfunctionJun 22, 2021Separation Failure; Separation Failure
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PHRENIC VEIN USING RUBY COIL LPS, A RUBY COIL LP DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, TWO RUBY COIL LPS FAILED TO DETACH USING THE HANDLE; THEREFORE, THE TWO RUBY COIL LPS WERE REMOVED. LATER, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL LP. THE PROCEDURE WAS COMPLETED USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE, 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 12044266 ↗MalfunctionJun 22, 2021Separation Failure; Separation Failure
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PHRENIC VEIN USING RUBY COIL LPS, A RUBY COIL LP DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, TWO RUBY COIL LPS FAILED TO DETACH USING THE HANDLE; THEREFORE, THE TWO RUBY COIL LPS WERE REMOVED. LATER, THE PHYSICIAN ADVANCED ANOTHER RUBY COIL LP INTO THE TARGET LOCATION AND ATTEMPTED TO DETACH IT USING THE SAME HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. SUBSEQUENTLY, THE PHYSICIAN MANUALLY DETACHED THE RUBY COIL LP. THE PROCEDURE WAS COMPLETED USING RUBY COILS, A RUBY COIL DETACHMENT HANDLE, 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 12044250 ↗MalfunctionMay 4, 2021Failure to Advance; Failure to Advance
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING RUBY COIL LPS. DURING THE PROCEDURE, TWO RUBY COIL LPS WERE STUCK IN THEIR INTRODUCER SHEATHS AND WOULD NOT ADVANCE. THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11773566 ↗MalfunctionApr 13, 2021Failure to Advance; Failure to Advance
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11662233 ↗MalfunctionFeb 19, 2021Separation Failure; Separation Failure
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COIL LPS, RUBY COILS, LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED RUBY COILS IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED A RUBY COIL LP INTO THE VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP AND THE SAME HANDLE. 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 11355735 ↗MalfunctionFeb 12, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO RUBY COIL LPS INTO THE MICROCATHETER, THE PHYSICIAN AND HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE TWO RUBY COIL LPS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE TWO RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP, A PACKING COIL LP AND THE SAME MICROCATHETER. 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 11324669 ↗MalfunctionFeb 12, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PORTAL VEIN USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO RUBY COIL LPS INTO THE MICROCATHETER, THE PHYSICIAN AND HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE TWO RUBY COIL LPS WOULD NOT ADVANCE AT ALL WITHIN THEIR INTRODUCER SHEATHS. THEREFORE, THE TWO RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP, A PACKING COIL LP AND THE SAME MICROCATHETER. 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 11324206 ↗MalfunctionFeb 5, 2021Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) BRANCH USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT ADVANCE FROM THE STARTING POSITION OF INTRODUCER SHEATH, AND THE PUSHER ASSEMBLY OF THE COIL BECAME BENT. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP. 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 11285443 ↗MalfunctionNov 8, 2020Failure to Advance; Failure to Advance
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING RUBY COIL LPS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, TWO RUBY COIL LPS WOULD NOT ADVANCE THROUGH THE MICROCATHETER. THEREFORE, THE RUBY COIL LPS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL (OF A DIFFERENT SIZE) AND THE SAME MICROCATHETER. 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 10806432 ↗MalfunctionOct 16, 2020Premature Separation; Premature Separation
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PELVIC USING RUBY COIL LPS. DURING THE PROCEDURE, A RUBY COIL LP WOULD NOT COME OUT OF THE INTRODUCER SHEATH. IT WAS REPORTED THAT WHILE ATTEMPTING TO REMOVE THE RUBY COIL LP UNDER FORCE, THE RUBY COIL LP KINKED. SUBSEQUENTLY, THE RUBY COIL LP WAS REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE USING ANOTHER RUBY COIL LP. THE RUBY COIL LP DETACHED IN THE INTRODUCER SHEATH. THEREFORE, THE RUBY COIL LP WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING RUBY 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 10691136 ↗MalfunctionSep 11, 2020Failure to Fold; Failure to Fold
THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN AN ARTERIOVENOUS FISTULA (AVF) USING RUBY COIL LPS, GUIDE CATHETER AND NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO THE VESSEL USING THE MICROCATHETER; HOWEVER, THE RUBY COIL LP WOULD NOT TAKE ITS INTENDED SHAPE. THE PHYSICIAN REPOSITIONED THE MICROCATHETER AND ATTEMPTED TO ADVANCE THE RUBY COIL LP; HOWEVER, THE COIL STILL WOULD NOT TAKE ITS INTENDED SHAPE. THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED ANOTHER RUBY COIL LP INTO THE VESSEL; HOWEVER, AFTER MULTIPLE ATTEMPTS, THE SAME ISSUE OCCURRED AND, THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL LP, SAME MICROCATHETER AND SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10523441 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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