ORBIT GALAXY ENPOWER XTRASOFT 641HX0204Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10878528009396), received between Apr 3, 2017 and Dec 23, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2019Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE COIL INTRODUCER ON THE 2MM X 4CM G2 HELICAL XTRASOFT COIL (641HX0204 / LOT# UNK) WAS CRACKED AND MADE IT DIFFICULTY TO PULL OUT FROM THE LOCK. THE COIL WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE REPORTED ISSUE RESULTED IN A 10-MINUTE DELAY IN THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE DEVICE WAS RETURNED FOR EVALUATION WITHOUT THE EMBOLIC COIL. DURING THE PRODUCT INVESTIGATION, IT WAS DETERMINED THAT THE EMBOLIC COIL WAS MECHANICALLY DETACHED FROM THE DELIVERY SYSTEM AS THERE WAS NO EVIDENCE THAT THE DETACHMENT CYCLE WAS INITIATED BASED ON THE APPEARANCE OF THE RESISTANCE HEATING (RH) COIL. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 10/30/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9513260 ↗
• MalfunctionAug 20, 2018Material Twisted/Bent; Premature Separation; Material Twisted/Bent; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A BASILAR TIP ARTERY ANEURYSM, THE 2MM X 4CM G2 HELICAL XTRASOFT (641HX0204/S13639) THERMO-MECHANICAL COIL DELIVERY SYSTEM WAS ADVANCED THROUGH THE BODY/SHAFT OF THE ECHELON (MEDTRONIC) MICROCATHETER, BUT RESISTANCE WAS ENCOUNTERED, AND THE COIL DELIVERY SYSTEM COULD NOT BE ADVANCED. THE COIL WAS REMOVED FROM THE MICROCATHETER; HOWEVER, UPON RETRIEVAL OF THE COIL, THE USER NOTED THAT THE COIL HAD DETACHED INSIDE OF THE MICROCATHETER HUB. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. PRIOR TO THIS COIL, THREE COILS WERE ADVANCED THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE USER DID NOT FASTEN THE ROTATING HEMOSTATIC VALVE (RHV) TOO TIGHTLY AROUND THE INTRODUCER. THE USER CONTINUOUSLY VERIFIED THAT THE INTRODUCER TIP AND THE MICROCATHETER HUB REMAINED ALIGNED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. WHEN THE UNUSUAL FRICTION OCCURRED DURING ADVANCEMENT, THE USER VERIFIED THAT THE FLUSH LINES WERE OPEN AND PROPERLY PRESSURIZED. NO ADDITIONAL DAMAGE WAS NOTED TO THE EMBOLIC COIL. THE USER DID NOT APPL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7797578 ↗
• MalfunctionApr 3, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY ANEURYSM, THERE WERE ISSUES WITH THREE DIFFERENT COILS, AND A PROWLER LPES. DELTAXSFT (DLX100206/C41704) WOULD NOT TAKE THE PROPER SHAPE PROPER SHAPE IN THE ANEURYSM (DID NOT TAKE THE PATH TO THE OPEN AREA OF THE ANEURYSM). THE POSITION OF THE MICROCATHETER WAS BELIEVED TO HAVE CONTRIBUTED TO THE COIL PERFORMANCE. THE COIL WAS REMOVED, RESHEATHED AND PUT ON BACK TABLE. WE THEN ATTEMPTED TO USE THE COIL AT A LATER TIME, IT WAS HYDRATED PER IFU, AND THE COIL WOULD NOT ADVANCE OUT OF THE SHEATH. THE COIL DID NOT APPEAR DAMAGED. A DELTAXSFT (DLX100256/C41706), LIKE THE PREVIOUS COIL, DID NOT CONFORM THE WAY THE PHYSICIAN WANTED, AND THE POSITION OF THE MICROCATHETER WAS FELT TO HAVE CONTRIBUTED TO THE POSITIONING ISSUE. THE COIL WAS REMOVED FOR RESHEATHING, BUT THE SHEATH SPLIT OPEN. THE COIL DID NOT APPEAR DAMAGED DURING THE PROCEDURE. NEXT, A G2 ORBIT GALAXY (641HX0204/C25452) WAS INTRODUCED INTO THE MICROCATHETER AND ADVANCED, BUT IT APPEARED THAT THE ENVOY DA GUIDE CATHETER (67125695DB/LOT UNK) SEEMED TO PINCH THE END OF THE PROWLER LPES MICROCATHETER (606S155FX/LOT UNK), AND THE G2 ORBIT GALA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6453287 ↗