ORBIT GALAXY 640CF0308Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704030225), received between Dec 1, 2016 and Mar 3, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN ORBIT GALAXY COIL (640CF0308, 31359779) WAS FILLED IN ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER (MC) WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 19-FEB-2025 INDICATING THAT THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THE COIL DID NOT STRETCH OR BECAME DAMAGED WHEN REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21507578 ↗
• MalfunctionOct 10, 2018Off-Label Use; Migration; Off-Label Use; Migration

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION FOR BLEEDING CAUSED BY AN INCORRECTLY PUNCTURED BRANCH OF THE LEFT SUPERFICIAL FEMORAL ARTERY, CONTRAST WAS PERFORMED AND CONFIRMED THAT THE 3MM X 8CM ORBIT GALAXY COMPLEX FILL (640CF0308/UNK LOT) COIL AND 3.5MM X 9CM ORBIT GALAXY COMPLEX FILL (640CF3509/UNK LOT) COIL FLOWED TO THE ¿PERIPHERY¿. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COILS ¿FLEW INTO FURTHER PERIPHERAL VESSEL¿. DETAILS SURROUNDING THE PROCEDURAL OUTCOME OF THIS SITUATION WERE NOT ABLE TO BE OBTAINED, BUT NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COILS HAD NOT BEEN DETACHED WHEN THE ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. APPROACH WAS MADE VIA THE RIGHT SUPERFICIAL FEMORAL ARTERY WITH A 5F CONTRAST CATHETER. THE MICROCATHETER WAS APPROACHED TO THE SUPERFICIAL FEMORAL ARTERY BRANCH. A 2MM X 2CM ORBIT GALAXY COMPLEX FILL COIL WAS ANCHORED. TWO COMPETITOR COILS WERE PLACED, AND THE COILS WERE NOT COILED DENSELY. A CONTRAST WAS PERFORMED WHICH CONFIRMED THAT THE 3MM X 8CM ORBIT GALAXY COMPLEX FILL (640CF0308/UNK LOT) FLOWED TO THE PERIPHERY. THE 3.5MM X 9CM ORBIT GALAX

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7954399 ↗
• MalfunctionMar 15, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING THE PROCEDURE IT WAS NOTED WHEN USING AN ORBIT GALAXY COMPLEX FILL COIL 3X8 (640CF0308/17397559) THAT THE PACKAGE OF THE COIL WAS LABELED INCORRECTLY. THE PROCEDURE WAS THE COIL EMBOLIZATION OF AN ANEURYSM AT THE RIGHT M1-2 JUNCTION. THE PATIENT WAS 67-YEAR-OLD MALE WHOSE VESSEL WAS MILDLY TORTUROUS AND NOT CALCIFIED. THE GUIDING CATHETER WAS ADVANCED TO THE PETROUS PORTION OF THE INTERNAL CAROTID ARTERY AND THE MICRO CATHETER WAS INSERTED INTO THE ANEURYSM. AFTER WHICH COMPETITOR¿S COILS WERE USED FOR FRAMING, BUT ITS FIGURE DID NOT FIT THE LESION. THEREFORE, COILS WERE REMOVED FROM THE PATIENT¿S BODY AND THEY WERE REPLACED WITH OG CMPLX FILL (COMPLAINT PRODUCT). THE PACKAGE OF THE COIL WAS OPENED AND PREPARATION WAS PERFORMED ACCORDING TO IFU. THE COIL WAS INSERTED INTO THE MICRO CATHETER AND IT WAS CONFIRMED THAT THE COIL COME OUT FROM THE CATHETER UNDER FLUOROSCOPY. IT WAS THE FOUND THAT THE COIL WAS SMALLER THAN THE REGULATION SIZE AND COME OUT IN A HELICAL SHAPE. IT WAS NOT THE SIZE DESCRIBED ON THE PACKAGE. THE COIL WAS REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6407289 ↗
• MalfunctionMar 10, 2017Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANEURYSM, THE PHYSICIAN EXPERIENCED RESISTANCE WHEN USING AN ORBIT GALAXY COMPLEX FILL 3X8 COIL. THE PATIENT¿S VESSELS WERE MODERATELY TORTUROUS AND NOT CALCIFIED. THE OG CMPLX FILL (COMPLAINT PRODUCT) WAS INSERTED INTO THE MICRO CATHETER (COMPETITOR¿S DEVICE) BUT THERE WAS RESISTANCE FELT AND COIL COULD NOT BE DETACHED. THEREFORE THE COIL WAS REPLACED WITH ANOTHER ONE (SAME SIZE, GALAXY) AND IT WAS USED WITH THE SAME MICRO CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WERE NO PATIENT INJURIES OR COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND A CONSTANT FLUSH WAS MAINTAINED AT ALL TIMES. NO VISIBLE DEFECT OR DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO (AND AFTER) THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WILL BE RETURNED FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6394641 ↗
• MalfunctionDec 1, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION FOR ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR AT THE LEFT INTERNAL ILIAC ARTERY, AN ORBIT GALAXY COMPLEX FILL COIL (640CF0308/ 17468434) FAILED TO DETACH. THE PHYSICIAN TRIED TO PLACE COIL TO THE TARGET LESION WITH A SYRINGE II. HOWEVER THE COIL COULD NOT BE DEPLOYED ALTHOUGH THE PRESSURE OF THE SYRINGE WAS APPLIED SEVERAL TIMES. THE SYRINGE WAS REPLACED WITH ANOTHER ONE, BUT THE COIL COULD NOT BE DEPLOYED. THE COIL WAS REPLACED WITH ANOTHER ONE (SAME SIZE, DIFFERENT LOT#), AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. 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 ON THE PRODUCTS PRIOR TO OR AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PATIENT VESSEL WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. IT WAS REPORTED THAT THE PRODUCT WOULD BE RETURNED FOR INVESTIGATION. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6138046 ↗