ORBIT GALAXY 640CF0824Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886704030386), received between Sep 13, 2016 and Apr 2, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Stretched” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, THE MICROCATHETER WAS IN PLACE AND THE 8MM X 24CM ORBIT GALAXY COMPLEX FILL (640CF0824 / 31651278) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A SECOND COIL, A 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX2505 / 31661861). THE SECOND COIL ENCOUNTERED THE SAME ISSUE; IT WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A THIRD COIL FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS A STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM ON THE INTERNAL CAROTID ARTERY. THE COILS WERE NOT STRETCHED WHEN THEY WERE REMOVED; THEY WERE STILL ATTACHED TO THE DELIVERY SYSTEMS. THERE WAS NO INTERRUPTION OF BLOOD FLOW. THE SYRINGE WAS FILLED WITH SALINE FROM A DEDICATED SOURCE. THE SAME SYRINGE WAS USED WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767327 ↗
• MalfunctionFeb 10, 2026Stretched; Separation Failure

  DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2025, THE MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND THE 8MM X 24CM ORBIT GALAXY COMPLEX FILL (640CF0824 / 31234521) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A SECOND COIL, A 6MM X 10CM ORBIT GALAXY COMPLEX FILL (640CF0610 / 31226101). THE SECOND COIL ENCOUNTERED THE SAME ISSUE; UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE SECOND COIL AND REPLACED IT WITH A THIRD COIL FROM ANOTHER MANUFACTURER AND COMPLETED THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THE PROCEDURE WAS PROLONGED BY ABOUT 15 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL OF THE PROCEDURE WAS THE POSTERIOR CEREBRAL ARTERY. PER THE INFORMATION, BOTH COILS WERE STRETCHED WHEN THEY WERE REMOVED; BOTH WERE STILL ATTACHED TO THE DELIVERY SYSTEMS. THERE WAS NO EVIDENCE OF OBSTRUCTED / REDUCTION OF BLOOD FLOW DUE TO THE REPORTED ISSUE. THE SYRINGE WAS FILLED WITH SALINE FROM A DED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306504 ↗
• MalfunctionAug 14, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, AN 8MM X 24CM ORBIT GALAXY COMPLEX FILL COIL (640CF0824 / 30790715) WAS THE FIRST COIL USED. IT COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN PULLED THE COIL AND THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) AT THE SAME TIME. AFTER INSPECTION, THE COIL WAS OBSERVED TO BE STRETCHED. THE PHYSICIAN USED ANOTHER ¿SAME LIKE¿ PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17546525 ↗
• MalfunctionSep 5, 2019Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, THE PHYSICIAN DID NOT LIKE THE SHAPE OF A 8X24 OG TDL CMPLX FILL COIL (640CF0824, 17684999) AND A 3X6 OG CMPLX XTRASOFT COIL (640CX0306, 17697695) DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RE-SHEATHING OF THE COILS, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT AND THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8966027 ↗
• MalfunctionApr 15, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE 8MM X 24CM ORBIT GALAXY COMPLEX FILL COIL (640CF0824 / LOT# UNKNOWN) COULD NOT BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THE PHYSICIAN REMOVED THE COIL AND THE MICROCATHETER (UNKNOWN BRAND)AT THE SAME TIME AND AFTER INSPECTING THE COIL, IT WAS OBSERVED TO BE STRETCHED. ANOTHER ORBIT GALAXY COMPLEX FILL COIL WAS USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION WITH THE REPORTED EVENT. IT WAS REPORTED THAT THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515435 ↗
• MalfunctionJan 23, 2018Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN ANEURYSM AT THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY ON A (B)(6) MALE PATIENT WITH HEAVILY TORTUOUS, MODERATELY CALCIFIED VESSEL, THE FIRST COIL SELECTED WAS DETERMINED TO BE UNDERSIZED AND WAS REPLACED WITH THE ORBIT GALAXY COMPLEX FILL COIL 8X24 (640CF0824) FROM LOT 17645079. A GUIDING CATHETER (FUBUKI, ASAHI INTECC), A MICROCATHETER (HEADWAY, TERUMO), A Y-CONNECTOR (TERUMO) AND A SYRINGE WERE ALSO USED FOR THE PROCEDURE. THE FRAMING WAS NOT SUCCESSFULLY COMPLETED AND THE ORBIT GALAXY COMPLEX FILL COIL BECAME UNRAVELED AFTER BEING PLACED IN AND OUT OF THE LESION SEVERAL TIMES. THE COIL WAS REPLACED WITH THE ORBIT GALAXY COMPLEX FILL (640CF0925) FROM LOT 17562306. THE NEW COIL BECAME STUCK AT THE DISTAL PORTION OF THE MICROCATHETER AND WAS REMOVED. THE COIL WAS REMOVED AND THE MICROCATHETER WAS FLUSHED BEFORE THE COIL WAS REINSERTED AND THE SAME ISSUE WAS ENCOUNTERED AT THE SAME DISTAL POSITION ON THE MICROCATHETER. THE REPORTED EVENT DID NOT RESULT IN ANY PATIENT INJURY OR ADVERSE EVENT. THERE WAS NO REPORTED COMPLICATION. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7213435 ↗
• InjuryNov 27, 2017Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF THE CAROTID CAVERNOUS SINUS FISTULA, AN ORBIT GALAXY COIL (640CF0824/ 17622795) BECAME ENTANGLED WITH PREVIOUSLY IMPLANTED COILS IN THE CAVERNOUS SINUS, UNRAVELED DURING ATTEMPTED WITHDRAWAL, AND WAS REMOVED BY A SNARE CATHETER. AFTER SEVERAL COILS WERE IMPLANTED IN THE CAVERNOUS SINUS, THE ORBIT GALAXY WAS INSERTED; HOWEVER, IT WAS TANGLED WITH THE OTHER COILS WHICH WERE ALREADY IN THE LESION AND COULD NOT MOVE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL, BUT IT UNRAVELED WHEN THE DELIVERY WIRE WAS PULLED. THEREFORE, THE COIL AND THE SL10 MICROCATHETER WERE REMOVED BY A SNARE CATHETER. A NEW MICROCATHETER AND NEW COILS WERE DELIVERED TO THE SHUNT POINT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. HOWEVER, DUE TO THE EVENT IT WAS DELAYED FOR 30 MINUTES. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE PATIENT¿S VESSEL WAS MODERATELY TORTUROUS AND MILDLY CALCIFIED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7060192 ↗
• MalfunctionSep 13, 2016Difficult To Position; Retraction Problem; Difficult To Position; Retraction Problem

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING A COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY THE ORBIT GALAXY (640CF0824/17383917) FAILED TO RE-SHEATH. A 6FR GUIDING SHEATH (COMPETITOR'S DEVICE) WAS APPROACHED FROM THE RIGHT FEMORAL ARTERY TO LEFT INTERNAL CAROTID ARTERY. A MICRO-CATHETER (COMPETITOR) WAS APPROACHED TO THE ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY AND THE COIL EMBOLIZATION OF THE ANEURYSM WAS STARTED. THE COMPLAINT ORBIT GALAXY WAS USED FOR PLACEMENT. THE PHYSICIAN COILED THE COIL SEVERAL TIMES; HOWEVER, HE WAS NOT ABLE TO FRAME THE COIL AS IT WAS SUPPOSED TO BE. THE COIL WAS NOT CONFORMING TO THE WALLS OF THE ANEURYSM DURING FRAMING. HE THEN TRIED TO RE-SHEATH THE COIL BUT COULDN'T DO IT AS THE ZIPPER WAS STUCK. EVENTUALLY, HE RETRIEVED THE COIL WITH MICROCATHETER AND USED A SPARE COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THE PATIENT WAS A (B)(6) YEAR OLD MALE, THE PATIENT VESSELS WERE NOT CALCIFIED AND THE LEVEL OF TORTUOUSNESS WAS MILD. THERE WERE ALSO NO PATIENT INJURIES OR COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5945088 ↗