ORBIT GALAXY ENPOWER XTRASOFT 641CX0410Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10878528009389), received between Dec 8, 2016 and Apr 1, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Stretched” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A CAROTID CAVERNOUS FISTULA THAT WAS 20 MM X 18.9 MM, IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED MUCH RESISTANCE WHILE ADVANCING THE 4 MM X 10 CM ORBIT GALAXY G2 COMPLEX XTRASOFT COIL (641CX0410 / S12733) TOWARD THE TARGET LESION THROUGH THE MICROCATHETER (HEADWAY DUO, MICROVENTION-TERUMO) THAT THE COIL BECAME STRETCHED WHEN IT WAS REMOVED. CONTINUOUS FLUSH WAS REPORTED TO HAVE BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHILE THE TARGET SITE WAS BEING ACCESSED. PRIOR TO THE RESISTANCE ISSUE ENCOUNTERED BY THE 4 MM X 10 CM ORBIT GALAXY G2 COMPLEX XTRASOFT COIL, THERE WERE 8 COILS THAT WERE SUCCESSFULLY ADVANCED THROUGH THE SAME MICROCATHETER WITHOUT ANY RESISTANCE. THERE WAS NO KINK ON THE MICROCATHETER THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THERE WAS A ONE TO ONE RELATIONSHIP BETWEEN THE DELIVERY TUBE THAT WAS MAINTAINED, BUT THIS WAS NOT VERIFIED WITH FLUOROSCOPY. IT WAS CONFIRMED THAT THERE WAS NO ENTANGLEMENT WITH PREVIOUSLY PLACED COIL. NO ADDITIONAL INTERVENTION WAS NEEDED; THE ENTIRE ORBIT GALAXY G2 COIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8469768 ↗
• MalfunctionAug 11, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, A G2 TDL COMPLEX XTRASOFT COIL (641CX0410/ S12732) FAILED TO DETACH USING TWO DETACHMENT CABLES (ECB00018200/S13482 AND ECB00018200/ S13745), AND DURING WITHDRAWAL, THE ECHELON 10 MICROCATHETER TARGET ACCESS WAS LOST AND IT WAS DECIDED TO PLACE NO FURTHER COILS. IT WAS REPORTED THAT AFTER THE COIL FAILED TO DETACH, THE DETACHMENT CONTROL CABLE AND DETACHMENT CONTROL BOX (DCB00000500/C20653) WERE REPLACED AND DETACHMENT PROCEDURE WAS REPEATED, BUT WITHOUT SUCCESS. FINALLY, THE COIL WAS RETRACTED, BUT TARGET ACCESS WAS LOST AND IT WAS DECIDED TO PLACE NO OTHER COILS. THERE HAD BEEN NO RESISTANCE BETWEEN THE G2 AND THE MICROCATHETER DURING ADVANCEMENT OR WITHDRAWAL. THE ENTIRE COIL WAS REMOVED FROM THE MICROCATHETER AND THE MICROCATHETER WAS STILL ATTACHED TO THE DELIVERY SYSTEM AND WAS NOT STRETCHED. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. NO LOW BATTERY LIGHT WAS SEEN DURING THE CASE AND NO FAULT LIGHT WAS SEEN. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. ONLY DURING THE FIRST ATTEMPT AT DETACHMENT DID THE DETACHMENT LIGHT ILLUMINATE AND THE AUDIBLE SIG

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6787788 ↗
• MalfunctionApr 11, 2017Difficult To Position; Stretched; Difficult To Position; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, AN ORBIT GALAXY G2 COIL (641CX0410/S00065) WAS DIFFICULT TO POSITION, AND STRETCHED WHILE BEEN PULLED BACK FROM THE ANEURYSM. THE EVENT OCCURRED DURING STENT ASSISTED COIL EMBOLIZATION OF A WIDE NECK SIPHON ANEURYSM. A NEUROFORM STENT WAS PLACED TO COVER THE NECK OF THE ANEURYSM. OTHER COILS HAD BEEN PLACED PRIOR TO PLACING THE G2 INTO THE ANEURYSM. THE PHYSICIAN WAS NOT SATISFIED WITH THE SHAPE OF THE COIL AFTER INSERTING 2/3 TO 3/4 INTO THE ANEURYSM, SO IT WAS PULLED BACK TO PLACE IT ONCE MORE. DURING THE PULL, THE COIL STRETCHED. THEY WERE ABLE TO PULL THE ENTIRE COIL BACK INTO THE MICROCATHETER WITHOUT DIFFICULTY, BUT IT WAS TOTALLY STRETCHED. THERE HAD BEEN NO FRICTION DURING INSERTION OF THE COIL AND NO APPARENT COIL ENTANGLEMENT. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. IT WAS REPORTED THAT THE COIL WAS USED AS NORMAL. THERE WERE NO PATIENT ADVERSE EVENTS AND THE PROCEDURE WAS COMPLETED WITH A SAME LIKE PRODUCT. THE EVENT RESULTED IN A 10 MINUTE PROCEDURE DELAY. THE MICROCATHETER HAD BEEN RESHAPED PRIOR TO USE WITH USE WITH THE SHAPING MANDREL. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6479922 ↗
• MalfunctionDec 8, 2016Premature Activation; Stretched; Premature Activation; Stretched

  IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT A GALAXY G2 COIL (641CX0410/P10371) WAS STUCK IN AN UNKNOWN MICROCATHETER. THE WHOLE ASSEMBLY HAD TO BE TAKEN OUT. IT IS UNKNOWN IF THE REPORTED EVENT CAUSED ANY PATIENT HARM OR SURGICAL DELAY. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6154932 ↗