RUBY Coil RBY4C0201-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI M424RBY4C02010), received between Dec 9, 2015 and Feb 15, 2019 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL WITHIN ITS INTRODUCER SHEATH AND, CONSEQUENTLY, THE PUSHER ASSEMBLY BECAME KINKED. THEREFORE, THE RUBY COIL WAS REMOVED, AND THE PROCEDURE WAS THEN COMPLETED USING ADDITIONAL RUBY COILS WITH THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8346163 ↗
• MalfunctionDec 31, 2018Device Damaged Prior to Use; Device Handling Problem; Device Damaged Prior to Use; Device Handling Problem

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, A RUBY COIL WAS ACCIDENTALLY CONTAMINATED. THE RUBY COIL WAS CONTAMINATED BEFORE USE AND THEREFORE, THE PROCEDURE WAS PERFORMED USING A NEW RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 8206910 ↗
• MalfunctionAug 9, 2018Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT GASTRIC ARTERY USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL THROUGH THE MICROCATHETER, THE PHYSICIAN APPLIED FORCE TO BOTH THE MICROCATHETER AND THE RUBY COIL¿S PUSHER ASSEMBLY; HOWEVER, THE COIL WOULD NOT FIT AS IT WAS TOO LONG; THEREFORE, THE PHYSICIAN REMOVED THE COIL. WHILE RETRACTING THE COIL, THE PHYSICIAN FELT RESISTANCE AND UPON REMOVAL, IT WAS NOTICED THAT THE COIL WAS STRETCHED AT THE DISTAL TIP AND ONLY HANGING BY THE THREAD. THE PROCEDURE WAS COMPLETED AT THIS POINT SINCE THE PHYSICIAN FELT THAT THE VESSEL WAS SUFFICIENTLY EMBOLIZED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7769233 ↗
• MalfunctionMay 3, 2018Kinked; Device Handling Problem; Kinked; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING A GI BLEED USING RUBY COILS. DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN INADVERTENTLY KINKED THE PUSHER ASSEMBLY OF A RUBY COIL WHILE ADVANCING THE RUBY COIL QUICKLY INTO THE NON-PENUMBRA MICROCATHETER. THE RUBY COIL WAS THEREFORE REMOVED, AND 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 Consequences Or Impact To Patient

  MAUDE report 7484932 ↗
• MalfunctionMar 1, 2018Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE UTERINE ARTERY USING RUBY COILS AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING THE HANDLE. THE PHYSICIAN THEN WAS UNABLE TO DETACH A RUBY COIL, DESPITE ATTEMPTING TO DETACH IT WITH THE HANDLE TWICE, AND DESPITE THE PET LOCK BEING BROKEN. THE RUBY COIL WAS THEREFORE REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW RUBY COIL AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7306430 ↗
• MalfunctionNov 17, 2017Kinked; Device Damaged Prior to Use; Kinked; Device Damaged Prior to Use

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE RADIOLOGIC TECHNOLOGIST INADVERTENTLY KINKED A RUBY COIL DETACHMENT ZONE WHILE REMOVING THE RUBY COIL FROM ITS DISPENSER HOOP. THE DETACHMENT ZONE BECAME KINKED PRIOR TO USE AND THEREFORE, THE RUBY COIL WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL.

  Patient problems: No Patient Involvement

  MAUDE report 7043348 ↗
• MalfunctionOct 11, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WOULD NOT ADVANCE PASS THE TIP OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY 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 6941006 ↗
• MalfunctionAug 23, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL BLEED USING RUBY COILS. IT WAS NOTED THE PATIENT¿S ANATOMY WAS SOMEWHAT TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE TWO RUBY COILS OUT OF THE NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND BOTH COILS WOULD NOT ADVANCE PASS THE SAME POINT IN THE MICROCATHETER. THEREFORE, THE RUBY COILS WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, A PLUG AND TWO ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6815517 ↗
• MalfunctionAug 2, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE RUBY COIL; HOWEVER, UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL AND FLUSHED THE COIL OUT. THE PHYSICIAN THEN RE-INSERTED THE LANTERN IN THE PATIENT¿S BODY AND ATTEMPTED TO ADVANCE A NEW RUBY COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED AND UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED IN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED COIL. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COILS AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6762309 ↗
• MalfunctionJun 23, 2017Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTROINTESTINAL ARTERY (GDA) USING RUBY COILS AND POD5S. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE POD5 THROUGH THE HUB OF THE NON-PENUMBRA MICROCATHETER; THEREFORE THE POD5 WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED A RUBY COIL. LATER IN THE PROCEDURE, THE PHYSICIAN RETRACTED AND REMOVED A RUBY COIL AFTER ADVANCING, DUE TO INCORRECT SIZING; HOWEVER WAS THEN UNABLE TO RE-SHEATH THE RUBY COIL. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6664482 ↗
• MalfunctionMar 15, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE ON (B)(6) 2017 USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME STUCK AND UNABLE TO ADVANCE. ALTHOUGH THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING IT, THE RUBY COIL WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS THEN HALTED FOR REASONS NOT RELATED TO ANY PENUMBRA PRODUCT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THE PHYSICIAN THEN REATTEMPTED THE COIL EMBOLIZATION PROCEDURE ON (B)(6) 2017 USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WAS UNABLE TO ADVANCE OUT OF THE MICROCATHETER; THEREFORE,IT WAS REMOVED. THIS SAME ISSUE OCCURRED AGAIN WITH A NEW RUBY COIL, AND THEN THE PROCEDURE WAS COMPLETED USING ANOTHER NEW RUBY COIL AND THE SAME NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6408232 ↗
• MalfunctionMar 15, 2017Failure to Advance; Physical Resistance; Mechanical Jam; Failure to Advance; Physical Resistance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE ON (B)(6) 2017 USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL BECAME STUCK AND UNABLE TO ADVANCE. ALTHOUGH THE PHYSICIAN EXPERIENCED RESISTANCE WHILE RETRACTING IT, THE RUBY COIL WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS THEN HALTED FOR REASONS NOT RELATED TO ANY PENUMBRA PRODUCT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THE PHYSICIAN THEN REATTEMPTED THE COIL EMBOLIZATION PROCEDURE ON (B)(6) 2017 USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL WAS UNABLE TO ADVANCE OUT OF THE MICROCATHETER; THEREFORE,IT WAS REMOVED. THIS SAME ISSUE OCCURRED AGAIN WITH A NEW RUBY COIL, AND THEN THE PROCEDURE WAS COMPLETED USING ANOTHER NEW RUBY COIL AND THE SAME NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. THE PHYSICIAN THEN REATTEMPTED THE COIL EMBOLIZATION PROCEDURE ON (B)(6) 2017 USING RUBY COILS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A NON

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6408227 ↗
• MalfunctionFeb 15, 2017Mechanical Jam; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING A GASTROINTESTINAL BLEEDING (GI BLEED) USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A COIL IN THE TARGET VESSEL USING ANOTHER MANUFACTURER¿S MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE SAME MICROCATHETER, THE RUBY COIL BECAME STUCK AROUND THE ROTATING HEMOSTASIS VALVE (RHV) AND THE PROXIMAL END OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REMOVED WITH THE RUBY COIL STILL STUCK INSIDE. THE PHYSICIAN THEN TOOK ADDITIONAL PICTURES AND SAW THAT THE BLEEDING HAD STOPPED; THEREFORE, THE PROCEDURE WAS ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6332141 ↗
• MalfunctionSep 22, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. WHILE ADVANCING THE SECOND RUBY COIL THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE THE RUBY COIL PAST THE TIP OF A NON-PENUMBRA MICROCATHETER. THEREFORE, THE RUBY COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND ANOTHER RUBY COIL. THE PHYSICIAN FLUSHED FREQUENTLY AND DID NOT USE A ROTATING HEMOSTASIS VALVE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5970313 ↗
• MalfunctionJun 3, 2016Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, AN INITIAL RUBY COIL WAS DEPLOYED INTO THE PATIENT BUT WAS THEN REMOVED BECAUSE IT WAS TOO LONG. THERE WAS NO REPORTED DEVICE DEFICIENCY WITH THIS FIRST COIL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW, SMALLER-SIZED RUBY COIL THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN); HOWEVER, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE RUBY COIL WOULD NOT ADVANCE PASS THE FRICTION LOCK AND OUT OF ITS INTRODUCER SHEATH. THEREFORE, THE RUBY COIL WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW RUBY COIL 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 5699444 ↗
• MalfunctionJan 21, 2016Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING TWO RUBY COILS THROUGH THE HUB OF ANOTHER MANUFACTURER'S MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5384642 ↗
• MalfunctionJan 21, 2016Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING TWO RUBY COILS THROUGH THE HUB OF ANOTHER MANUFACTURER'S MICROCATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5384461 ↗
• MalfunctionDec 9, 2015Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO DETACH A RUBY COIL IN THE ANEURYSM AND REMOVED THE COIL FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5279423 ↗