ORBIT GALAXY ENPOWER 641CF0620Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10878528009594), received between Sep 22, 2017 and Oct 6, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Kinked” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, THE PHYSICIAN INTRODUCED A 6X20 ORBIT GALAXY COMPLEX FILL COIL (641CF0620, L11790) IN THE RHV VALVE, WHILE ADVANCING COIL THROUGH MIDWAY IN THE UNSPECIFIED MICROCATHETER (MC), THE DOCTOR FACED RESISTANCE. AFTER TRYING FOR FEW TIMES, THE PHYSICIAN WITHDREW THE COIL WITHOUT ADDITIONAL INTERVENTIONS AND USED ANOTHER ONE. THE COIL WAS DEPLOYED, AND THE CASE WAS FINISHED SUCCESSFULLY. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED AND ENTANGLED WITH ITSELF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583049 ↗
• MalfunctionMar 8, 2021Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO A RIGHT M1 ANEURYSM, THE COIL OF A 6X20 ORBIT GALAXY (641CF0620, L13123) BECAME DETACHED IN A .014 SL10 MICROCATHETER (MC) WHILE ADVANCING OF THE COIL DELIVERY SYSTEM. HENCE, THE DOCTOR DECIDED TO WITHDRAW THE COIL WITHOUT ADDITIONAL INTERVENTION AND PLACED ANOTHER SAME COIL TO COMPLETE THE CASE. THE SURGERY WAS DELAYED BY 10 MINUTES DUE TO THE EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION RECEIVED INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THERE WAS NOT BEEN AN ATTEMPT TO DETACH THE COIL PRIOR TO THE PREMATURE DETACHMENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. IT WAS NOT NECESSARY TO REMOVE THE MC WITH THE ORBIT GALAXY. THE MC WAS JUST TAKEN OUT WITH THE HELP OF A MICROWIRE, THEY REMOVED COIL FROM THE MICROCATHETER. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11435299 ↗
• MalfunctionOct 8, 2018Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT A PATIENT WITH AN ANEURYSM AT THE APEX OF THE LEFT CAROTID ARTERY, AFTER OTHER COILS WERE PLACED INTO THE ANEURYSM, THE ORBIT GALAXY G2 TDL COMPLEX FILL COIL 6MM X 20CM (641CF0620 / S14413) WAS POSITIONED BUT THE COIL DID NOT DETACH. AN ADDITIONAL FIVE MINUTES WERE SPENT TO REPEAT THE ATTEMPT TO DETACH THE COIL BEFORE THE CONNECTING CABLE THAT WAS USED TO DETACH THE PREVIOUS COILS WERE REPLACED. THE G2 COIL PREMATURELY DETACHED IN THE MICROCATHETER DURING THE ATTEMPT TO MOVE IT INTO THE ANEURYSM. THE PHYSICIAN WAS ABLE TO PUSH THE COIL INTO THE ANEURYSM USING THE DELIVERY WIRE. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OF ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7943650 ↗
• MalfunctionMay 7, 2018Kinked; Separation Failure; Kinked; Separation Failure

  A REPORT WAS RECEIVED THAT THE 6X20 G2 TDL COMPLEX FILL (641CF0620/UNK LOT) THERMO-MECHANICAL COIL FAILED TO DETACH DURING THE CASE. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7490004 ↗
• MalfunctionApr 19, 2018Kinked; Stretched; Kinked; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A 7 MM DIAMETER VERTEBRAL ARTERY ANEURYSM, THE PHYSICIAN ENCOUNTERED STIFF RESISTANCE WHILE PUSHING THE 6 MM X 20 CM ORBIT GALAXY G2 STRETCH RESISTANT COMPLEX FILL TDL THERMO-MECHANICAL DETACHABLE COIL DELIVERY SYSTEM (DCS) (641CF0620/P11909) THROUGH THE HEADWAY (MICROVENTION) MICROCATHETER. THE COIL DELIVERY SYSTEM WAS STUCK IN THE MICROCATHETER DUE TO THE RESISTANCE AND COULD NO LONGER ADVANCE. THE PHYSICIAN ATTEMPTED TO ADVANCE THE COIL MULTIPLE TIMES WITHOUT SUCCESS. THE COIL WAS SUBSEQUENTLY REMOVED FROM THE MICROCATHETER HUB. THE PRODUCT WAS NOTED TO BE DAMAGED UPON REMOVAL FROM THE MICROCATHETER. ADDITIONAL ORBIT GALAXY G2 COILS AND COMPETITOR COILS WERE USED WITH THE SAME MICROCATHETER TO COMPLETE THE CASE. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE SURGERY WAS DELAYED A ¿FEW¿ MINUTES DUE TO THE EVENT. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO USE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THREE COILS WERE ADVANCED THROUGH THE SAME MICROCATHETER PRIOR TO THIS COIL. THERE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7443999 ↗
• MalfunctionSep 22, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A G2 CMPLX FILL COIL (641CF0620/S10184) WAS USED DURING A PROCEDURE WHERE THE COIL COULD NOT BE DETACHED. THE COIL WAS DELIVERED, BUT NOT DEPLOYED. THE COIL WAS THEN RE-SHEATHED AND RE-DEPLOYED BUT THE COIL WOULD NOT DETACH. THE COIL WAS REMOVED AND DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6886174 ↗