ORBIT GALAXY ENPOWER 641CF0412Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10878528009556), received between Mar 20, 2017 and Mar 12, 2021 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionMar 12, 2021Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TARGETING AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH THE TARGET ANEURYSM BEING AN INFERIOR OUTPOUCHING ANEURYSM, THERE WAS RESISTANCE DURING THE INTRODUCTION OF THE 4MM X 12CM G2 TDL COMPLEX FILL COIL (641CF0412 / L12055) ENCOUNTERED RESISTANCE. DURING THE ATTEMPT TO REMOVE THE COIL DUE TO THE ENCOUNTERED RESISTANCE, IT BECAME STRETCHED. THE EVENT RESULTED IN A 5-MINUTE PROCEDURE DELAY. ANOTHER COIL WAS USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO BALLOON / STENT OR NECK REMODELING DEVICE WAS USED. THE COMPLAINT COIL WAS USED WITH THE ECHELON¿ 10 MICROCATHETER (MEDTRONIC). CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE COIL HAD NOT BEEN WITHDRAWN AND REPOSITIONED, THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER DURING THE ACCESSING OF THE TARGET ANEURYSM. PRIOR TO THE ISSUE ENCOUNTERED WITH THE COMPLAINT COIL, THERE WERE THREE (3) PREVIOUS COILS THAT WENT THROUGH THE SAME MICROCATHETER WITHOUT ANY RESISTANCE. THERE WAS NO KINK N

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475571 ↗
• InjuryAug 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WHO UNDERWENT A COIL EMBOLIZATION PROCEDURE THAT TARGETED A BASILAR ANEURYSM TWO YEARS AGO IN 2017, REACHED OUT TO A SALES REP TO REPORT THAT SHE IS SUFFERING FROM A HEADACHE THAT HAS TURNED INTO A CHRONIC, PERMANENT HEADACHE. THE PATIENT WOULD LIKE TO KNOW THE MATERIAL COMPOSITION OF THE 4MM X 12CM ORBIT GALAXY G2 COMPLEX FILL COIL (641CF0412/LOT#: UNK) WITH RESPECT TO A POTENTIAL INTOLERANCE/ALLERGY.

  Patient problems: Headache

  MAUDE report 8936552 ↗
• MalfunctionJul 5, 2017Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING BASILAR ARTERY ANEURYSM COILING, A GALAXY G2 COIL (641CF0412/S12782) COULD NOT BE PUSHED IN THE PROWLER LPES MICROCATHETER (606S155X/17161634). THE COIL WAS REMOVED WITH THE MICROCATHETER. THE G2 DID NOT APPEAR DAMAGED. THERE WAS NO PATIENT INJURY OR SIGNIFICANT DELAY IN THE PROCEDURE. THEY COMPLETED THE PROCEDURE WITH ANOTHER MICROCATHETER AND COIL. IT WAS REPORTED THAT THE PRODUCT WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6687116 ↗
• MalfunctionMar 20, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A RECOILING PROCEDURE OF A BASILAR TIP ANEURYSM AN ORBIT GALAXY G2 FILL 4 MM X 12 CM COIL FAILED TO DETACH. THE PROCEDURE WAS RE-COILING OF A BIFURCATION ANEURYSM. THE FIRST EMBOLIZATION PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE, POST COILING THERE WAS ENLARGEMENT AND RECANALIZATION OF THE ANEURYSM. THE TYPE OF COILS USED DURING THE FIRST COILING PROCEDURE IS UNKNOWN. THIS PROCEDURE WAS PERFORMED TO RE-TREAT THE ANEURYSM. THE COMPLAINT ORBIT GALAXY COIL DID NOT DETACH EVEN AFTER SEVERAL ATTEMPTS WERE MADE AND UPON CHANGING THE ENPOWER CONNECTING CABLE. PRIOR TO THE COMPLAINT COIL FOUR OTHER G2 COILS WERE USED WITHOUT ANY PROBLEMS. THE COMPLAINT COIL WAS THEN REPLACED WITH A COMPETITOR¿S COIL AND THE PROCEDURE WAS COMPLETED. PRIOR TO ATTEMPT TO DETACH WITH THE COMPLAINT COIL, THE DETACHMENT MARKER WAS DISTAL TO THE PROXIMAL MICROCATHETER MARKER, BUT STILL ¿TOUCHED¿. IT WAS VERIFIED UNDER FLUORO THAT THERE WAS NO STRESS AGAINST THE MICROCATHETER OR THE DELIVERY TUBE. UPON PRESSING THE ¿POWER¿ BUTTON ALL THE LIGHTS HAD ILLUMINATED, A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED AND THE GREEN SYSTEM READY LIGHT ILLUMINATED. DURING THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6417009 ↗