ORBIT GALAXY ENPOWER 641CF0515Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10878528009570), received between Oct 19, 2016 and Mar 11, 2019 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionMar 11, 2019Stretched; Separation Failure; Stretched; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION INTERVENTION PROCEDURE OF A CEREBRAL ANEURYSM AT THE CAROTID SYPHON THAT WAS CARRIED OUT CORRECTLY, IT WAS REPORTED THAT THE 5MM X 15CM G2 STRETCH RESISTANT COMPLEX FILL COIL (641CF0515 / S14134) FAILED TO DETACH. IT WAS NOT CLEAR IF THE DETACHMENT ISSUE IS RELATED TO THE COIL OR TO THE CODMAN® CONNECTING CABLE (CCB00015700 / S13256). THE G2 COIL WAS REMOVED WITHOUT ANY ADVERSE CONSEQUENCE TO THE PATIENT; IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM AND WAS NOT STRETCHED WHEN IT WAS REMOVED. IT WAS CONFIRMED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE CONTACT LIGHT DID NOT LIGHT UP WHEN THE COIL WAS CONNECTED, AND THE GREEN SYSTEM READY LIGHT DID NOT ILLUMINATE. THE AUDIBLE SIGNAL DID NOT SOUND DURING THE DETACHMENT CYCLE. ALL THE CONNECTIONS FIT PROPERLY WITHOUT THE APPLICATION OF EXCESSIVE FORCE. THERE WAS NO REPORT OF ANY PATIENT INJURY AS A RESULT OF THE FAILURE OF THE G2 COIL FAILING TO DETACH. THE REPORTED EVENT DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE G2 COIL IS AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409940 ↗
• MalfunctionMar 2, 2017Positioning Failure; Positioning Failure

  THE CONTACT FROM THE FACILITY REPORTED THAT THE ORBIT GALAXY COIL (641CF0515/C12282) DID NOT DETACH DURING THE PROCEDURE. NO PATIENT INJURY OCCURRED. THE DEVICE WAS NOT AVAILABLE FOR RETURN. THERE WAS NO SIGNIFICANT CLINICAL DELAY REPORTED. THE PROCEDURE WAS CONTINUED WITH ANOTHER COIL. THERE WERE NO DAMAGES NOTED TO THE COIL AND COIL DELIVERY SYSTEM PRIOR TO USE OR AFTER REMOVAL. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED. NO PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. NO LOW BATTERY LIGHT WAS SEEN DURING THE CASE. NO FAULT LIGHT WAS SEEN. THE SYSTEM READY LIGHT DID NOT ILLUMINATE. THE DETACHMENT LIGHT DID NOT ILLUMINATE DURING THE DETACHMENT CYCLE AND THE AUDIBLE SIGNAL DID NOT BEEP. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT USE OF EXCESSIVE FORCE. THE SAME CONNECTING CABLE AND DETACHMENT CONTROL BOX WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6375132 ↗
• InjuryFeb 9, 2017Material Separation; Stretched; Material Separation; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COILING PROCEDURE, A G2 ORBIT COIL (641CF0515/ P10965) STRETCHED AND THEN SEPARATED IN TWO PIECES WHILE REPOSITIONING. RESULTING IN THE COIL PROTRUDING INTO THE INTERNAL CAROTID ARTERY. A STENT WAS DEPLOYED TO JAIL THE HANGING COIL TO THE INTERNAL CAROTID ARTERY. THE ECHELON 10 MICROCATHETER HAD NOT BEEN REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER. THERE WAS RESISTANCE WHILE RE-POSITIONING THE COIL, AND COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS MAY HAVE CONTRIBUTED TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6314112 ↗
• MalfunctionOct 19, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A BASILAR ARTERY ANEURYSM, A G2 TDL COMPLEX FILL COIL (641CF0515/ P11905) COULD NOT BE DETACHED, AND WAS SUCCESSFULLY REMOVED TOGETHER WITH THE SL 10 MICROCATHETER. THE COIL WAS NOT VISIBLY STRETCHED, AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO RESISTANCE BETWEEN THE G2 AND THE MICROCATHETER. A SECOND DETACHMENT CABLE WAS USED; HOWEVER, IT WAS REPORTED THAT THE SAME ENPOWER DETACHMENT CONTROL BOX (DCB) AND CABLE WERE USED SUCCESSFULLY TO DETACH SUBSEQUENT COILS. THE GREEN LIGHT OF THE BOX WAS ON FOR BOTH CABLES, BUT NEVERTHELESS NO DETACHMENT WAS OBTAINED. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. LOW BATTERY LIGHT WAS NOT SEEN DURING THE CASE, AND FAULT LIGHT WAS NOT SEEN. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEPED. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE PROCEDURE WAS COMPLETED AND THE DELAY WAS LESS THAN 30 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6039723 ↗