ORBIT GALAXY ENPOWER XTRASOFT 641CX2505Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10878528008931), received between Sep 22, 2016 and Apr 14, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Separation 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 14, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING COIL EMBOLIZATION OF AN ANEURYSM TO THE ARTERIA COMMUNICANS ANTERIOR (ACOM) WITH AN ACUTE BEND AT THE ORIGIN OF THE ANTERIOR CEREBRAL ARTERY (ACA) A1, THE CATHETER NAVIGATED THE BEND AND WAS POSITIONED INSIDE THE ANEURYSM. HOWEVER, BUT BOTH COILS, A 2.5X5 G2 COMPLEX XTRASOFT COIL (641CX2505, S10442) AND A 2X8 G2 HELICAL XTRASOFT COIL (641HX0208, S15050) FAILED TO NEGOTIATE THE BEND AND THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THROUGH THE ECHELON10 MICROCATHETER (MC) AND TRACKING THROUGH THAT BEND. HENCE AFTER SOME ATTEMPTS. BOTH COILS WERE REMOVED, AND THE CASE WAS FINISHED WITH THE COMPETITOR¿S COILS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT OTHER DEVICES WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE. THE EVENT DID NOT RESULT IN THE LOSS OF CEREBRAL TARGET POSITION. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MC. CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE FAILURE ANALYSIS LAB, THE COILS OF THE TWO DEVICES RECEIVED WERE FOUND STRETCHED DURING THE MICROSCOPIC EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11664043 ↗
• MalfunctionJun 7, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WITH THE TARGET SITE ON THE INTERNAL CAROTID ARTERY (ICA) WHILE ATTEMPTING TO DETACH THE 2.5MM X 5CM G2 COMPLEX XTRASOFT COIL (641CX2505 / P11754), THE ENPOWER DETACHMENT CONTROL BOX (DCB00000500 / C27718) DID NOT WORK PROPERLY AND THE COIL DID NOT DETACH. THE COIL WAS REMOVED STILL ATTACHED TO THE DELIVERY SYSTEM AND NOT STRETCHED. A PRE-DEPLOYMENT CHECK WAS PERFORMED AND THERE WAS NO ISSUE NOTED DURING THE CHECK. THERE WAS NO EVIDENCE OF LOW BATTERY, THE BOX HAD BEEN USED WITH PREVIOUS COILS; THE BOX HAD BEEN USED OVER THE LAST SEVERAL MONTHS WITHOUT ISSUE. THE COIL WAS REPLACED, AND THE SAME ISSUE OCCURRED. IT WAS REPORTED THAT THE CUSTOMER CONTINUED TO USE THE DCB WITH THREE MORE COILS BECAUSE THEY HAD ASSUMED THE ISSUE WAS RELATED TO THE COILS AND NOT THE BOX. THE CUSTOMER REPLACED THE DCB AND DETERMINED THAT THE ENPOWER DETACHMENT CONTROL BOX DID NOT WORK PROPERLY AND RESULTED IN THE FAILED DETACHMENT OF THE COILS. THIS COIL AND THE OTHER THREE COILS WERE NOT RE-CHALLENGED AFTER THE DETACHMENT BOX WAS REPLACED. IT WAS REPORTED THAT THE COIL WAS DISCARDED ONCE IT WAS DETERMINED THAT THE ISSUE WAS WITH THE DCB NOT W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8680283 ↗
• MalfunctionJun 7, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WITH THE TARGET SITE ON THE INTERNAL CAROTID ARTERY (ICA) WHILE ATTEMPTING TO DETACH THE 2.5MM X 5CM G2 COMPLEX XTRASOFT COIL (641CX2505 / P10893), THE ENPOWER DETACHMENT CONTROL BOX (DCB00000500 / C27718) DID NOT WORK PROPERLY AND THE COIL DID NOT DETACH. THE COIL WAS REMOVED STILL ATTACHED TO THE DELIVERY SYSTEM AND NOT STRETCHED. A PRE-DEPLOYMENT CHECK WAS PERFORMED AND THERE WAS NO ISSUE NOTED DURING THE CHECK. THERE WAS NO EVIDENCE OF LOW BATTERY, THE BOX HAD BEEN USED WITH PREVIOUS COILS; THE BOX HAD BEEN USED OVER THE LAST SEVERAL MONTHS WITHOUT ISSUE. THE COIL WAS REPLACED, AND THE SAME ISSUE OCCURRED. IT WAS REPORTED THAT THE CUSTOMER CONTINUED TO USE THE DCB WITH THREE MORE COILS BECAUSE THEY HAD ASSUMED THE ISSUE WAS RELATED TO THE COILS AND NOT THE BOX. THE CUSTOMER REPLACED THE DCB AND DETERMINED THAT THE ENPOWER DETACHMENT CONTROL BOX DID NOT WORK PROPERLY AND RESULTED IN THE FAILED DETACHMENT OF THE COILS. THIS COIL AND THE OTHER THREE COILS WERE NOT RE-CHALLENGED AFTER THE DETACHMENT BOX WAS REPLACED. IT WAS REPORTED THAT THE COIL WAS DISCARDED ONCE IT WAS DETERMINED THAT THE ISSUE WAS WITH THE DCB NOT W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8680276 ↗
• MalfunctionAug 16, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE 2.5MM X 5CM G2 COMPLEX XTRASOFT (641CX2505/S14210) THERMO-MECHANICAL COIL DELIVERY SYSTEM WAS ADVANCED THROUGH THE ECHELON-10 (MEDTRONIC) MICROCATHETER BODY/SHAFT BUT STRONG RESISTANCE WAS ENCOUNTERED, AND THE COIL BECAME STUCK AND COULD NO LONGER BE ADVANCED. THE EMBOLIC COIL WAS NOTED TO BE STRETCHED BEFORE EXITING THE MICROCATHETER. THE COIL WAS SUBSEQUENTLY REMOVED FROM THE MICROCATHETER. THE EMBOLIC COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED. THE SAME MICROCATHETER WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. PRIOR TO THIS COIL, TWO COILS WERE ADVANCED THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE USER CONTINUOUSLY VERIFIED THAT THE INTRODUCER TIP AND MICROCATHETER HUB REMAINED ALIGNED. WHEN THE UNUSUAL FRICTION OCCURRED DURING ADVANCEMENT, THE USER VERIFIED THAT THE FLUSH LINES WERE OPEN AND PROPERLY PRESSURIZED. THE PRODUCT WILL BE RETURNED FOR EVALUATION. THE CONCOMITANT MICROCATHE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7790336 ↗
• MalfunctionSep 22, 2016Stretched; Physical Resistance; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THERE WAS RESISTANCE WHILE ADVANCING A G2 COMPLEX XTRASOFT COIL (641CX2505/ S10323) THROUGH THE SL10 MICROCATHETER, AND THE G2 COIL APPEARED STRETCHED. THE COIL HAD BEEN TESTED OUTSIDE OF THE BODY PER IFU INSTRUCTIONS AND THE INTRODUCER WAS ADVANCED INTO THE HUB OF THE MICROCATHETER. THE COIL WAS UNLOCKED AND ADVANCEMENT WAS INITIALLY SMOOTH AND SUCCESSFUL. THE COIL THEN OFFERED RESISTANCE TO ADVANCEMENT. THE COIL WAS RETRACTED COMPLETELY INTO THE INTRODUCER AND REMOVED FROM THE RHV. THE SAME COIL WAS THEN RE-INSERTED INTO THE RHV AND ADVANCED, INITIALLY WITH SUCCESS AND NO RESISTANCE, BUT THEN THE COIL AGAIN OFFERED RESISTANCE. THE COIL WAS REMOVED AGAIN FROM THE MICROCATHETER, RETRACTED COMPLETELY INTO THE INTRODUCER AND WAS DISCARDED; HOWEVER, IT WAS NOTED THAT THE COIL WAS STRETCHED. THE MICROCATHETER DID NOT APPEAR DAMAGED. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5969667 ↗