ORBIT GALAXY ENPOWER XTRASOFT 641HX0208Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10878528009419), received between Feb 28, 2017 and Oct 19, 2021 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• MalfunctionOct 19, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE RIGHT ANTERIOR COMMUNICATING ARTERY (ACON), A 2X8 ORBIT GALAXY ENPOWER XTRASOFT COIL (641HX0208, S10340) WAS NOT ABLE TO PLACE THROUGH THE PROWLER LPES 14, STRAIGHT MICROCATHETER (MC) SMOOTHLY AND WAS REQUIRED MORE PUSH. HENCE, THE DOCTOR DECIDED TO WITHDRAW THE COIL WITHOUT THE NEED TO ADDITIONAL INTERVENTION AND REPLACE IT WITH ANOTHER GALAXY COIL TO COMPLETE THE CASE. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY. 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 A LOSS OF CEREBRAL TARGET POSITION. THE MICROCATHETER WAS NOT DAMAGED DURING MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE ACTUAL COIL DID NOT APPEAR DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656326 ↗
• 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 11664050 ↗
• DeathMar 26, 2019Material Fragmentation; Positioning Problem; Migration; Premature Separation; Material Fragmentation; Positioning Problem; Migration; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE MIDDLE-AGE MALE PATIENT PRESENTED WITH A SEVERE SUBARACHNOID HEMORRHAGE THAT REQUIRED INTUBATION AND THE PLACEMENT OF A NON-CERENOVUS INTRACRANIAL DRAIN. DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A SEVERE SUBARACHNOID HEMORRHAGE, THE TARGET VESSEL WAS REACHED, AND THE FIRST COIL (A 3.5 MM X 7.5 CM COMPLEX G2 XTRASOFT COIL: 641CX3575 / S10344) WAS IMPLANTED WITHOUT ANY ISSUE, THE 2MM X 8CM G2 HELICAL XTRASOFT COIL (641HX0208 / P11479) WAS THE SECOND COIL CHOSEN FOR IMPLANTATION. THE PHYSICIAN ATTEMPTED TO IMPLANT THIS SECOND COIL BUT AFTER 4 ¿ 5 ATTEMPTS, IT WAS REPORTED THAT THE ¿INTRODUCER BROKE DOWN¿ AND THE COIL COULD NEITHER BE RETRACTED NOR PLACED INSIDE THE ANEURYSM. AN AMPLATZ GOOSE NECK¿ MICRO SNARE (MEDTRONIC) WAS USED IN ATTEMPT TO RETRIEVE THE COIL BUT WAS UNSUCCESSFUL. IN THE END, THE PHYSICIAN ¿PULLED THE COIL TO THE VESSEL WALL.¿ CONTROL ANGIOGRAPHY REVEALED BLOOD CLOTS IN THE PARENT ARTERY. THE THROMBOSIS RESOLVED WITH THE ADMINISTRATION OF INTEGRILIN (5 ML). A REVIEW OF COMPUTED TOMOGRAPHY (CT) IMAGING CONFIRMED THAT THE PATIENT¿S CONDITION HAD NOT WORSENED FOL

  Patient problems: Death; No Code Available; Thrombosis

  MAUDE report 8453369 ↗
• MalfunctionFeb 28, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DURING A COILING PROCEDURE A G2 HELICAL XTRASOFT 2X8 COIL FAILED TO DETACH. THE PROCEDURE WAS COILING OF A 5MM MIDDLE CEREBRAL ARTERY ANEURYSM. THE PATIENT'S VESSELS WERE NOT TORTUROUS. A PRE-DEPLOYMENT CHECK WAS NOT PERFORMED, UPON PRESSING THE POWER BUTTON ALL THE LIGHTS HAD ILLUMINATED AND THE GREEN SYSTEM READY LIGHT ILLUMINATED; HOWEVER, THE DETACHMENT LIGHT DID NOT ILLUMINATE DURING THE DETACHMENT CYCLE AND THERE WAS NO AUDIBLE SIGNAL BEEP. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. A NEW COIL WAS USED TO COMPLETE THE PROCEDURE. THE SAME CONNECTING CABLE AND DCB WERE USED SUCCESSFULLY WITH THE SUBSEQUENT COILS. THERE WERE NO DAMAGES NOTED TO THE COIL/COIL DELIVERY SYSTEM/DETACHMENT SYSTEM PRIOR TO USE OR AFTER REMOVAL. THE COMPLAINT COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT AND THERE WAS NO STRETCHING NOTED ON THE COIL. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS OR SURGICAL DELAYS RELATED TO DEVICE OR REPORTED EVENT. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6364708 ↗