ORBIT GALAXY ENPOWER 641CF1030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10878528009655), received between Mar 9, 2021 and May 23, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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.

• MalfunctionMay 23, 2022Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A THROMBECTOMY PROCEDURE AFTER THROMBUS REMOVAL WHEN IMAGING WAS PERFORMED, DISSECTION OF THE INTERNAL CAROTID ARTERY (ICA) WAS CONFIRMED. FOR THE ICA DISSECTION, THERE WAS AN ATTEMPT TO IMPLANT THE 4.0MM X 30MM ENTERPRISE® 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC403000 / 5711205), BUT THE POSITION WAS NOT DETERMINED AS THE PHYSICIAN HAD INTENDED AND THE ENTERPRISE VRD WAS RECAPTURED. THE UNSPECIFIED MICROCATHETER WAS REPLACED WITH A PROWLER SELECT PLUS 45° (606S255X / 30397530), AND IT WAS ADVANCED AND AN ATTEMPT TO IMPLANT THE ENTERPRISE VRD AGAIN, HOWEVER, THE ENTERPRISE GOT STUCK INSIDE THE MICROCATHETER; A CONTINUOUS FLUSH WAS MAINTAINED. THE DELIVERY WIRE WAS REMOVED FROM THE PATIENT, BUT THE STENT COMPONENT IS LEFT BEHIND INSIDE THE MICROCATHETER. AS IMPLANTATION OF THE ENTERPRISE VRD WAS NOT POSSIBLE, THE PROCEDURE WAS TERMINATED. IT WAS REPORTED THAT THE PATIENT IS UNDER FOLLOW-UP OBSERVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470325 ↗
• InjuryFeb 23, 2022Activation Failure; Activation Failure

  HOLD GN 2-23-22IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A STENT-ASSISTED COIL EMBOLIZATION OF A VERTEBRAL ARTERY DISSECTING ANEURYSM, THE OPENING OF THE PROXIMAL PORTION OF THE 4MM X 30MM ENTERPRISE 2 STENT (ENC403000/5711194) WAS POOR. IT WAS STATED THAT THERE WAS A POSSIBILITY THAT THE STENT WAS STUCK IN THE NARROWED AREA. THE FLARE ON THE FRONT SIDE SEEMED TO BE HARD TO EXPAND DESPITE FULLY DEPLOYMENT. THEREFORE, A SYOURYU BALLOON CATHETER WAS USED IN AN ATTEMPT TO EXPAND THE STENT. HOWEVER, THE FLARE OF THE STENT BECAME DAMAGED BECAUSE THE ¿WIRE IN THE FRONT SIDE WAS STICKING TOGETHER¿. A SNARE DEVICE WAS THEN USED IN ATTEMPT TO RETRIEVE THE DEVICE AND THE STENT WAS GRASPED BY THE SNARE FROM THE DISTAL END, BUT ¿IT CAME OFF ON THE WAY¿; ¿IT BECAME THE STATE THAT FLOATING IN THE AIR¿. THE PHYSICIAN THEN TRIED TO USE A 6MM SOLITAIRE STENT RETRIEVER, BUT THE STENT WAS NOT ABLE TO BE PULLED. HOWEVER, SINCE THE FLARE AT THE PROXIMAL PORTION WAS DEFORMED, THE PHYSICIAN WAS FINALLY ABLE TO GRASP IT WITH A SNARE AND REMOVE IT. THE ENTERPRISE COMPLAINT DEVICE WAS REPLACED WITH A NEUROFORM ATLAS (STRYKER) STENT. COILS WERE SUBSEQUENTLY IMPLANTED, AND THE PROCEDURE WAS COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583832 ↗
• MalfunctionMar 9, 2021Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION OF A WIDE NECK OF THE BASILAR ARTERY, A PROWLER SELECT PLUS MICROCATHETER (PRODUCT/LOT NUMBER UNKNOWN) WAS DELIVERED TO THE LEFT POSTERIOR CEREBRAL ARTERY (PCA) FROM A 5F ENVOY GUIDING CATHETER. A 23MM ENTERPRISE STENT WAS USED FOR IMPLANTATION, BUT THE LENGTH WAS NOT ENOUGH TO COVER THE NECK. THEREFORE, IT WAS REPLACED WITH A 4MMX30MM ENTERPRISE2 NO TIP STENT (ENC403000, 5711194). IT WAS ATTEMPTED TO BE IMPLANTED FROM THE PROWLER SELECT PLUS (PSP) BUT THERE WAS A RESISTANCE FELT TO DEPLOY AT THE CATHETER. THE COMPLAINT STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. THE MICROCATHETER WAS REPLACED WITH A SL10, STRYKER MICROCATHETER (MC) AND A NEUROFORM ATLAS STENT, STRYKER WAS USED. THE PROCEDURE CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11445287 ↗