ORBIT GALAXY ENPOWER 641CF1230Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10878528009662), received between Aug 15, 2017 and Jul 18, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2022Malposition of Device; Difficult to Advance; Malposition of Device; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A LESION ON THE RIGHT VERTEBRAL ARTERY (VA), A 4.0MM X 39MM NO DISTAL TIP ENTERPRISE® 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC403900 / 6920525) WAS USED; THE JAILING TECHNIQUE WAS ATTEMPTED AT FIRST, BUT THE MICROCATHETER FOR COIL EMBOLIZATION COULD NOT BE SET AT THE IDEAL POSITION, AS A RESULT, THE COIL EMBOLIZATION WAS ABANDONED. AFTER SETTING UP THE 7FR ASAHI FUBUKI GUIDE CATHETER (ASAHI INTECC), A SYNCHRO SELECT¿ 14 GUIDEWIRE (STRYKER), AND A CONCOMITANT PROWLER SELECT PLUS (CATALOG/LOT# UNKNOWN) AT THE DISTAL VA, WHEN THE GUIDEWIRE WAS REMOVED AND THE ENTERPRISE STENT WAS BEING DELIVERED, THERE WAS A HEAVY RESISTANCE FELT AND THE ENTERPRISE STENT COULD NOT BE ADVANCED, EVEN WHEN PUSHED WITH CONSIDERABLE FORCE. THE ENTERPRISE STENT WAS REMOVED ONCE AND RE-FLUSHED. IT WAS DELIVERED AGAIN, BUT STILL COULD NOT ADVANCE. IT WAS REPORTED THAT ¿THE COMPLAINT PRODUCT WAS PUSHED SOMEHOW AND DEPLOYED.¿ DURING DEPLOYMENT, THE STENT COMPONENT SLIPPED AND SLID DOWN FROM THE DISTAL SIDE. THE FINAL DEPLOYMENT WAS COMPLETED WITH THE STENT COMPONENT A LITTLE CLOSER TO THE INSERTION SITE THAN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15048626 ↗
• MalfunctionAug 17, 2021Retraction Problem; Failure to Advance; Retraction Problem; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM, THE COMPLAINT DEVICE, A 4MM X 39MM ENTERPRISE 2 ((B)(4)) WAS USED BUT IT BECAME STUCK ON AN UNSPECIFIED MICROCATHETER (MC). IT WAS DIFFICULT TO REMOVE THE COMPLAINT DEVICE, THEREFORE, IT WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEW MICROCATHETER AND STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12331615 ↗
• MalfunctionJun 4, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PHYSICIAN INITIALLY USED THE FRED¿ FLOW DIVERTER STENT (MICROVENTION) WAS USED FOR THE PATIENT WITH VA. HOWEVER, THE BLOOD VESSEL WAS DAMAGED DURING THE PROCEDURE SO THE PHYSICIAN DECIDED TO USE THE 4.0MM X 39MM NO DISTAL TIP ENTERPRISE® 2 VASCULAR RECONSTRUCTION DEVICE (ENC403900 / 11161339) WITH THE 150CM X 5CM, 2 MARKERS PROWLER SELECT PLUS MICROCATHETER (606S255X / 30105233). THE MICROCATHETER WAS ADVANCED TO THE PLACEMENT POSITION AND WATER / FLUSH WAS PASSED INTO THE SHEATH AND DELIVERED INTO THE MICROCATHETER AS PER THE INSTRUCTION FOR USE (IFU). HOWEVER, THE ENTERPRISE STENT WAS NOT ABLE TO ADVANCE FURTHER FROM APPROXIMATELY 1CM BEFORE THE FIRST MARKER ON THE MICROCATHETER. THE PHYSICIAN TRIED TO RETRACT THE ENTERPRISE STENT BUT IT WAS DIFFICULT. HE REPEATED THE RETRACTION ATTEMPT SEVERAL TIMES. THE ENTERPRISE STENT WAS INSERTED INTO THE MICROCATHETER AGAIN BUT THE SAME ISSUE OCCURRED. IT WAS REPORTED THAT THERE WAS NO KINK ON THE MICROCATHETER. THE MICROCATHETER AND THE ENTERPRISE STENT WERE REMOVED FROM THE PATIENT. AN ASAHI FUBUKI GUIDE CATHETER (ASAHI INTECC) WAS USED AS A DISTAL ACCESS CATHETER. A PROWLER SELECT PLUS 45-DEG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943551 ↗
• MalfunctionSep 22, 2020Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 4.0MM X 39MM ENTERPRISE® 2 VASCULAR RECONSTRUCTION DEVICE ((B)(4)) WAS USED DURING THE PROCEDURE TARGETING A LESION, WHICH HAS A WIDE NECK. THE PHYSICIAN ATTEMPTED TO IMPLANT THE STENT, BUT RESHEATHED IT ONCE IN ORDER TO CHANGE THE IMPLANTATION POSITION. DURING THE ATTEMPT TO DEPLOY THE STENT, IT BECAME STUCK IN THE CONCOMITANT PROWLER SELECT PLUS MICROCATHETER, AND AS A RESULT, COULD NOT BE IMPLANTED. THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE STENT INSIDE. THE STENT WAS REPLACED, AND THE REPLACEMENT STENT WAS IMPLANTED. DUE TO INFECTIOUS DISEASE, THE COMPLAINT DEVICE IS NOT AVAILABLE FOR RETURN. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10568255 ↗
• MalfunctionSep 6, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT THE CAROTID-CAVERNOUS FISTULA (CCF), THE PHYSICIAN ATTEMPTED TO DEPLOY THE G2 COMPLEX FILL COIL 12MM X 30CM (641CF1230 / P10026), HE EXPERIENCED RESISTANCE WHILE ADVANCING THE COIL THROUGH THE MICROVENTION HEADWAY MICROCATHETER. THE PHYSICIAN REMOVED THE G2 COIL FROM THE MICROCATHETER AND OBSERVED THAT THE COIL HAD BECOME STRETCHED. THE COIL WAS REPLACED; THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE USING THE SAME HEADWAY MICROCATHETER TO DEPLOY SEVEN ADDITIONAL COILS. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED ISSUE. THE G2 COIL WAS INDICATED AS AVAILABLE TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7851836 ↗
• MalfunctionAug 15, 2017Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION AT AN UNKNOWN LOCATION, AN ORBIT GALAXY G2 COIL (641CF1230/ S10226) COULD NOT BE DETACHED. THE SAME SYSTEM WAS USED SUCCESSFULLY TO DETACH A SUBSEQUENT COIL WITH NO PROBLEM. THERE WAS NO DAMAGE NOTED TO ANY OF THE PRODUCTS USED. NO FURTHER INFORMATION WAS GIVEN OR COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6794614 ↗