ORBIT GALAXY ENPOWER XTRASOFT 641CX0202Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10878528008894), received between Feb 10, 2017 and Jan 13, 2025 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 28MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452800 / 9061786) WAS IMPEDED IN THE PROXIMAL SECTION OF THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31359808) AND COULD NOT ADVANCE FURTHER. THE PHYSICIAN ATTEMPTED TO RETRACT THE STENT AND OBSERVED THAT THE STENT WAS DETACHED FROM THE DELIVERY WIRE IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE MICROCATHETER AND STENT FROM THE PATIENT AND REPLACED BOTH DEVICES TO COMPLETE THE PROCEDURE, WHICH WAS REPORTEDLY PROLONGED BY APPROXIMATELY 15 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138549 ↗
• MalfunctionAug 27, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 28MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452800 / 8582191) WAS IMPEDED IN THE INTRODUCER SHEATH AND COULD NOT BE PUSHED INTO THE MICROCATHETER (UNSPECIFIED BRAND). THE PHYSICIAN RETRACTED THE STENT AND OBSERVED THAT THE STENT BODY WAS PREMATURELY SEPARATED FROM THE DELIVERY WIRE. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE WITH THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 21-AUG-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS A STENT-ASSISTED EMBOLIZATION TARGETING A POSTERIOR COMMUNICATING ARTERY ANEURYSM. THE CONCOMITANT MICROCATHETER USED WAS A PROWLER SELECT PLUS MICROCATHETER. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO DAMAGE NOTED ON THE STENT / STENT DELIVERY SYSTEM WHEN IT WAS REMOVED. THE REPLACEMENT STENT WAS ANOTHER 4.5MM X 28MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452800). THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077534 ↗
• MalfunctionJul 8, 2022Activation Problem; Activation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR STENT PLACEMENT PROCEDURE, THE 4.5MM X 28MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452800 / 6812662) PASSED THROUGH THE MICROCATHETER AND THE PHYSICIAN TRIED TO RELEASE THE STENT, BUT THE DISTAL MARKERS OF THE STENT COULD NOT BE OPENED. THE PHYSICIAN RETRACTED THE STENT AND SWITCHED TO A COMPETITOR DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14960008 ↗
• InjuryJun 13, 2022Material Separation; Material Separation

  IT WAS REPORTED FROM A HEALTH AUTHORITY THAT A PATIENT UNDERWENT A VASCULAR STENT PLACEMENT WITH AN ENTERPRISE 4.5MM X 28MM VASCULAR RECONSTRUCTION DEVICE WITH NO DISTAL TIP (ENC452800/6920541), WHICH EXPERIENCED A FRACTURE IN THE GUIDEWIRE AND BROKE DURING THE PROCEDURE. PER THE EVENT DESCRIPTION, UNDER THE GUIDANCE OF A 0.035 SUPER SLIDING GUIDE WIRE AND PATH, THE 8F GUIDE CATHETER (MPA1-CORDIS) AND THE HEAD END OF THE INTRACRANIAL SUPPORT CATHETER WAS INSERTED INTO THE PETROUS SEGMENT OF THE LEFT INTERNAL CAROTID ARTERY BY COAXIAL TECHNOLOGY. THE M1 SEGMENT OF THE LEFT MIDDLE CEREBRAL ARTERY WAS OCCLUDED BY ANGIOGRAPHY, WITH AN MTICI OF 0. THE INTRACRANIAL SUPPORT CATHETER WAS GENTLY AND SLOWLY PLACED AT THE M1 OCCLUSION OF THE LEFT MIDDLE CEREBRAL ARTERY. NO BLOOD FLOW WAS FOUND, SO IT WAS CONNECTED TO A NEGATIVE PRESSURE DEVICE FOR SUCTION TWICE, BUT NO THROMBUS WAS FOUND. CONSIDERING THE HIGH POSSIBILITY OF ATHEROSCLEROTIC STENOSIS AND OCCLUSION, A 0.014-INCH MICRO GUIDE WIRE WAS SELECTED, AND WITH THE HELP OF A MICROCATHETER AND THE GUIDANCE OF A PATH MAP, THE HEAD END OF THE MICRO GUIDE WIRE CAREFULLY CROSSED THE OCCLUDED SEGMENT AND WAS PLACED AT THE END OF THE M2 SEGMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14680668 ↗
• MalfunctionMar 23, 2022Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST EMBOLIZATION, A 4.5MMX28MM ENTERPRISE WITH NO DISTAL TIP INTRACRANIAL NEUROVASCULAR STENT (ENC452800, 6610132) BECAME IMPEDED PROXIMAL OF THE PROWLER SELECT PLUS MICROCATHETER (606S255X, 30679785). IT COULD NOT BE ADVANCED ANYMORE. THE PHYSICIAN ATTEMPTED TO RETRACT THE STENT, BUT IT WAS FOUND TO BE RELEASED IN MICROCATHETER. THE PHYSICIAN REMOVED THE STENT WITH THE MICROCATHETER TOGETHER, THEN SWITCHED TO A NEW STENT AND MICROCATHETER TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13860092 ↗
• MalfunctionFeb 11, 2022Break; Failure to Advance; Break; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE STENT COMPONENT OF THE 4.5MM X 28MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452800 / 6218824) WAS IMPEDED IN THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) AND COULD NOT ADVANCE FURTHER. THE PHYSICIAN RETRACTED THE STENT AND OBSERVED THAT THE BODY OF THE STENT COMPONENT WAS DEFORMED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518695 ↗
• InjuryDec 15, 2021Activation Failure; Activation Failure

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: ZHANG K, XIA JC, GAO HL, GAO BL, WANG YF, LI ZS, LI TX, WANG ZL. CASE REPORT: DOUBLE MICRO-GUIDEWIRE TECHNIQUE FOR EMERGENT RESCUE OF PROXIMAL STENT COLLAPSE DURING RECANALIZATION OF NONACUTE OCCLUSION OF VERTEBRAL ARTERY. FRONT NEUROL. 2021 SEP 3;12:671158. DOI: 10.3389/FNEUR.2021.671158. PMID: 34539544; PMCID: PMC8446545. OBJECTIVE AND METHODS: THE ARTICLE REPORTS A CASE WITH V4 SEGMENT OCCLUSION OF THE RIGHT VERTEBRAL ARTERY TREATED WITH ENDOVASCULAR STENT ANGIOPLASTY. LOT NUMBER IS NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED EVENT: 4.5MM X 28MM ENTERPRISE STENT. OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: 2.0 × 13 MM GATEWAY BALLOON (STRYKER), 300-CM TRAXCESS MICRO-GUIDEWIRE (0.014 INCH, MEDTRONIC), ECHELON 10 MICROCATHETER (MEDTRONIC). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: A MALE PATIENT IN HIS 50S UNDERWENT ENDOVASCULAR STENT ANGIOPLASTY OF A V4 SEGMENT OCCLUSION WITH A 4.5MM X 28MM ENTERPRISE STENT. THE ENTERPRISE STENT DEPLOYED AT THE OCCLUSION SEGMENT WAS COLLAPSED AT THE PROXIMAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13012344 ↗
• MalfunctionDec 3, 2021Premature Activation; Difficult to Advance; Material Twisted/Bent; Premature Activation; Difficult to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ANEURYSM EMBOLIZATION PROCEDURE, THE PHYSICIAN FELT RESISTANCE DURING THE ATTEMPT TO DELIVER THE 4.5MM X 28MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452800 / 6451017) THROUGH THE MICROCATHETER AND OBSERVED THAT THE STENT COMPONENT WAS ALREADY RELEASED / DEPLOYED IN THE MICROCATHETER. THE STENT BODY WAS OBSERVED TO BE DEFORMED. ANOTHER STENT WAS USED AS A REPLACEMENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. PHOTO OF THE COMPLAINT DEVICE WAS INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925265 ↗
• InjurySep 13, 2021Activation Problem; Activation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING A LEFT INTERNAL CAROTID ARTERY COMMUNICATING SEGMENT ANEURYSM, THE DISTAL END OF THE 4.5MM X 28MM ENTERPRISE¿ NO DISTAL TIP VASCULAR RECONSTRUCTION DEVICE (ENC452800 / 5852771) DEPLOYED NORMALLY AT THE TIME OF DEPLOYMENT, BUT THE PROXIMAL PORTION OF THE STENT DID NOT FULLY EXPAND. THE PHYSICIAN MADE AN UNSUCCESSFUL ATTEMPT TO FULLY EXPAND / OPEN THE STENT TINES USING A GUIDEWIRE TO MASSAGE THE STENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY. THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: 3.5MM (LENGTH) X 3.7MM (WIDTH) X 2.4MM (HEIGHT). THE DIAMETER OF THE PARENT ARTERY WAS 3.7MM; THE DIAMETER OF THE VESSEL DISTAL TO THE TARGET ANEURYSM WAS 3.4MM. THE ENTERPRISE STENT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A SINGLE PROCEDURAL IMAGE WAS PROVIDED WITH THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12465621 ↗
• MalfunctionFeb 10, 2017Stretched; Stretched

  AS REPORTED BY HEALTH CARE PROFESSIONAL, A G2 COMPLEX XTRASOFT COIL GOT STUCK IN A MICRO CATHETER (COMPETITOR¿S DEVICE) AND GOT STRETCHED. THE PATIENT WAS DIAGNOSED WITH SUBARACHNOID HEMORRHAGE AND THE PROCEDURE WAS FOR COILING OF ANTERIOR COMMUNICATING ARTERY ANEURYSM. IT WAS REPORTED THAT PRIOR TO THE COMPLAINT COIL THREE COILS WERE INSERTED THROUGH THE SAME MICROCATHETER WITHOUT ANY RESISTANCE. THE RESISTANCE WITH THE COMPLAINT COIL WAS FELT BEFORE THE COIL EXITED THE MICROCATHETER; WHEN THE COIL WAS BEING ADVANCED THROUGH THE MID SHAFT OF THE CATHETER. AFTER STRETCHING WAS NOTED THE ENTIRE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH THE COIL STILL ATTACHED TO THE DELIVERY SYSTEM. ONLY THE COMPLAINT COIL WAS REMOVED, THE REPORTED EVENT DID NOT REQUIRE THE REMOVAL OF THE CATHETER. THERE WERE NO ADVERSE EVENTS OR SURGICAL DELAYS DUE TO THE REPORTED EVENT. THERE WERE NO KINKS NOTED ON THE MICROCATHETER AND AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER AT ALL TIMES. IT WAS INITIALLY REPORTED THAT THE COMPLAINT PRODUCT IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6321645 ↗