ORBIT GALAXY ENPOWER XTRASOFT 641CX0304Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10878528008924), received between Oct 26, 2016 and May 13, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Premature Activation” (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.

• MalfunctionMay 13, 2021Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, DURING A STENT IMPLANTATION FOR INTRACRANIAL STENOSIS, A 4.5MMD 37MML ENTERPRISE STENT VASCULAR RECONSTRUCTION WITH NO DISTAL TIP (ENC453700, LOT UNKNOWN) DEPLOYED IN THE PROWLER SELECT PLUS 150/5C MICROCATHETER (606S255X, LOT UNKNOWN). IT WAS REPORTED THAT STENT BODY WAS DETACHED FROM THE GUIDEWIRE WHEN THE STENT WAS BEING ADVANCED WITHIN THE MICROCATHETER (MC). THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS STORED, INSPECTED, AND PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NOTHING UNUSUAL NOTED ABOUT THE STENT DELIVERY SYSTEM PRIOR TO USE. THERE WAS NO RESISTANCE DURING INTRODUCTION OF THE ENTERPRISE THROUGH THE MICROCATHETER. THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED. THERE WERE NO SURGICAL DELAYS DUE TO THE EVENT. NO EXCESSIVE FORCE WAS APPLIED AT ANY TIME. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822078 ↗
• MalfunctionSep 6, 2018Premature Activation; Premature Activation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF THE POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM, THE PHYSICIAN DEPLOYED THE G2 COMPLEX XTRASOFTTM COIL 3MM X 4CM (641CX0304 / C31006) INSIDE THE ANEURYSM BUT DURING THE DEPLOYMENT, THE ECHELON 10 MICROCATHETER (MEDTRONIC) KICKED BACK. THE PHYSICIAN RE-SHEATHED THE COIL AND REPOSITIONED THE MICROCATHETER WITH THE GUIDEWIRE AND ATTEMPTED TO REDEPLOY THE COIL; THE MICROCATHETER KICKED BACK A SECOND TIME AND DURING THE ATTEMPT TO RE-SHEATH THE COIL, THE BECAME DETACHED IN THE MICROCATHETER. THE MICROCATHETER AND THE COIL WERE BOTH REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE REPORTED EVENT DID NOT RESULT IN ANY PROCEDURAL DELAY OR ANY PATIENT CONSEQUENCE. THE G2 COIL WAS INDICATED AS AVAILABLE TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7851823 ↗
• MalfunctionMar 16, 2017Stretched; Stretched

  AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE A G2 COMPLEX XTRASOFT 3X4 COIL STRETCHED. THE PROCEDURE WAS COIL EMBOLIZATION OF AN ANEURYSM AT THE POSTERIOR INFERIOR CEREBELLAR ARTERY. PATIENT WAS REPORTED TO HAVE NORMAL VESSEL CHARACTERISTICS. THE G2 COMPLEX XTRASOFT COIL WAS TOO BIG FOR THE ANEURYSM, THEREFORE THE COIL WAS RESHEATHED AND REMOVED. WHEN REMOVED THE PHYSICIAN NOTED THAT THE COIL HAD STRETCHED AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE PHYSICIAN DID NOT FEEL SECURE TO PLACE THE COIL AGAIN AS THE PHYSICIAN FELT THAT THE COIL MIGHT BREAK DURING THE SECOND PLACEMENT. NO DAMAGES WERE NOTED ON THE COIL WHEN INSPECTED PRIOR TO USE. AN ADEQUATE CONTINUOUS FLUSH WAS NOT MAINTAINED THROUGH THE CATHETER. THERE WERE NO KINKS IN THE MICROCATHETER PRIOR TO USE OR UPON REMOVAL AND THERE WAS NO RESISTANCE EXPERIENCED WHEN THE USING THE COIL. THE PROCEDURE WAS COMPLETED USING OTHER UNKNOWN COIL. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS OR SURGICAL DELAYS RELATED TO DEVICE OR REPORTED EVENT. THE COMPLAINT COIL IS AVAILABLE FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6409495 ↗
• MalfunctionOct 26, 2016Difficult To Position; Stretched; Difficult To Position; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A G2 COMPLEX XTRASOFT COIL (641CX0304/C25122) DID NOT FIT IN THE INTERNAL CAROTID ARTERY ANEURYSM AT THE FIRST PUSH, AND WHEN PULLING THE COIL INTO THE SL10 MICROCATHETER, THE COIL STRETCHED. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE EXCELSIOR SL 10, 0.0165" MICROCATHETER AND THERE WAS NO RESISTANCE BETWEEN THE MICROCATHETER AND COIL. THE MICROCATHETER DID NOT APPEAR DAMAGED. NO ADDITIONAL INTERVENTION WAS REQUIRED. UNFORTUNATELY, THE PHYSICIAN HAD LEFT THE HOSPITAL WHERE THE EVENT OCCURRED. FOR THIS REASON, IT WAS DIFFICULT TO GATHER FURTHER INFORMATION. IT WAS UNKNOWN IF THE EVENT RESULTED IN PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. IT WAS ALSO UNKNOWN IF THE MICROCATHETER HAD BEEN REPOSITIONED OVER THE COIL WHILE THE COIL WAS DEPLOYED OR PARTIALLY DEPLOYED OUT OF THE DISTAL END OF THE MICROCATHETER, OR IF A ONE TO ONE RELATIONSHIP BETWEEN THE COIL AND DELIVERY TUBE WAS VERIFIED WITH FLUORO PRIOR TO REPOSITIONING. IT WAS ALSO UNKNOWN IF COIL ENTANGLEMENT WAS SUSPECTED TO CONTRIBUTE TO THE EVENT. IT WAS REPORTED THAT THE DEVICE WOULD BE RETURN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6057629 ↗