ORBIT GALAXY ENPOWER 641CF2505Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10878528009457), received between Nov 16, 2020 and Dec 2, 2024 — classified as 3 injuries, 6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2024Activation Failure; Activation Failure

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 14MML WNO DSTL TP INTRACRANIAL STENT (ENC451400, 8878743) WAS PLACED IN THE TARGET SITE AND TRIED TO RELEASE. THE 3 DISTAL MARKERS OF THE STENT DID NOT FULLY OPEN OR EXPAND AS INTENDED. THE PHYSICIAN ONLY RETRACTED THE STENT AND DELIVERED IT AGAIN TO RELEASE, BUT THE 3 DISTAL STENT MARKERS WERE STILL FAILED TO OPEN. MICRO-GUIDEWIRE WAS USED TO MASSAGE THE STENT, BUT THE MARKERS WERE STILL UNABLE TO OPEN. THE PHYSICIAN ONLY RETRACTED THE STENT AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION WAS RECEIVED ON 21-NOV-2024 INDICATING THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE STENT DID NOT APPEAR DAMAGED. IT WAS NOTED THAT THE RELEASE SITE AT THE HEAD END IS STRAIGHT BLOOD VESSEL. MASSAGE WAS APPLIED TO THE HEAD END GUIDE WIRE. THERE WAS NO STENT MIGRATION OR EMBOLIZATION OF THE STENT. THE PROCEDURE WAS DELAYED BY 5 MINUTES DUE TO THE EVENT BUT WAS NOT CLINICALLY SIGNIFICANT. ADDITIONAL EVENT INFORMATION WAS RECEIVED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20821097 ↗
• MalfunctionAug 6, 2024Product Quality Problem; Product Quality Problem

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION, AN EU ENT4.5MMD 14MML WNO DSTL TP INTRACRANIAL STENT (ENC451400, 8337176) WAS PLACED IN TARGET SITE AND STARTED TO RELEASE. THE PHYSICIAN COULD NOT OBSERVE THE STENT POSITIONING MARKER AND THE STENT DISTAL MARKERS. THE DOCTOR RETRACTED THE STENT AND GAVE UP IMPLANTING A STENT AND COMPLETED THE SURGERY. ADDITIONAL EVENT INFORMATION RECEIVED ON 30-JUL-2024 INDICATED THAT THE RADIOPAQUE OF DEVICE WAS WORSE THAN EXPECTED. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918247 ↗
• MalfunctionJun 15, 2022Migration; Migration

  IT WAS REPORTED THAT A PATIENT WITH A PREOPERATIVE DIAGNOSIS OF A LEFT MIDDLE CEREBRAL ARTERY ANEURYSM, CEREBRAL ISCHEMIC LESION, AND EMPHYSEMA UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF THE ANEURYSM USING AN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 4.5MM X 14MM WITH NO DISTAL TIP (ENC451400/6920527). PER THE EVENT DESCRIPTION, TRANSFEMORAL PUNCTURE, WHOLE CEREBRAL ANGIOGRAPHY, AND STENT-ASSISTED COIL EMBOLIZATION OF THE ANEURYSM WERE PERFORMED. A MICROCATHETER WAS PLACED IN POSITION AND THE PHYSICIAN PUSHED THE STENT INTO THE MICROCATHETER. THE DELIVERY WIRE WAS IN GOOD CONDITION DURING ITS DELIVERY, BUT IT DID NOT REACH THE REFERENCE MARKERS ON THE DELIVERY WIRE. AT THAT MOMENT, UNDER FLUOROSCOPY, THE PHYSICIAN FOUND THE STENT HAD BEEN RELEASED TO THE DISTAL END OF THE LESION SITE WITHOUT INTENTION, AND THAT THE STENT DID NOT COVER THE LESION SITE CORRECTLY. THE PHYSICIAN THEN RELEASED A NEW ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 4.5MM X 14MM WITH NO DISTAL TIP (ENC451400) AND IT COMPLETELY COVERED THE ANEURYSM. AFTER SOME TIME, THE ANGIOGRAM SHOWED THAT THE STENT HAD MIGRATED ANTERIORLY. THE PROCEDURE WAS PROLONGED FOR ABOUT AN HOUR AND A HALF. THE PATIENT IS CURRENTLY ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14697005 ↗
• InjuryJun 15, 2022Premature Activation; Migration; Premature Activation; Migration

  IT WAS REPORTED THAT A PATIENT WITH A PREOPERATIVE DIAGNOSIS OF A LEFT MIDDLE CEREBRAL ARTERY ANEURYSM, CEREBRAL ISCHEMIC LESION, AND EMPHYSEMA UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF THE ANEURYSM USING AN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 4.5MM X 14MM WITH NO DISTAL TIP (ENC451400/6920527). PER THE EVENT DESCRIPTION, TRANSFEMORAL PUNCTURE, WHOLE CEREBRAL ANGIOGRAPHY, AND STENT-ASSISTED COIL EMBOLIZATION OF THE ANEURYSM WERE PERFORMED. A MICROCATHETER WAS PLACED IN POSITION AND THE PHYSICIAN PUSHED THE STENT INTO THE MICROCATHETER. THE DELIVERY WIRE WAS IN GOOD CONDITION DURING ITS DELIVERY, BUT IT DID NOT REACH THE REFERENCE MARKERS ON THE DELIVERY WIRE. AT THAT MOMENT, UNDER FLUOROSCOPY, THE PHYSICIAN FOUND THE STENT HAD BEEN RELEASED TO THE DISTAL END OF THE LESION SITE WITHOUT INTENTION, AND THAT THE STENT DID NOT COVER THE LESION SITE CORRECTLY. THE PHYSICIAN THEN RELEASED A NEW ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 4.5MM X 14MM WITH NO DISTAL TIP (ENC451400) AND IT COMPLETELY COVERED THE ANEURYSM. AFTER SOME TIME, THE ANGIOGRAM SHOWED THAT THE STENT HAD MIGRATED ANTERIORLY. THE PROCEDURE WAS PROLONGED FOR ABOUT AN HOUR AND A HALF. THE PATIENT IS CURRENTLY ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14696964 ↗
• MalfunctionApr 11, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR STENT PLACEMENT PROCEDURE, THE 4.5MM X14MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC451400 / 6610104) WAS IMPEDED IN THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 30615314) AND COULD NOT BE ADVANCED NOR RETRACTED. THE PHYSICIAN RETRACTED THE STENT WITH THE MICROCATHETER TOGETHER AND CHANGED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. TWO PHOTOS OF THE OF THE COMPLAINT DEVICES WERE INCLUDED IN THE COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079212 ↗
• InjuryDec 23, 2021Migration; Migration

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: VAJDA Z, SCHMID E, GÜTHE T, KLÖTZSCH C, LINDNER A, NIEHAUS L, SPERBER W, PETERS J, ARNOLD G, BÄZNER H, HENKES H. THE MODIFIED BOSE METHOD FOR THE ENDOVASCULAR TREATMENT OF INTRACRANIAL ATHEROSCLEROTIC ARTERIAL STENOSES USING THE ENTERPRISE STENT. NEUROSURGERY. 2012 JAN;70(1):91-101; DISCUSSION 101. DOI: 10.1227/NEU.0B013E31822DFF0F. PMID: 21778921. OBJECTIVE AND METHODS: THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE PROCEDURAL SAFETY AND STENOSIS RECURRENCE RATE BY THE USE OF A STENT WITH REDUCED RADIAL FORCE (ENTERPRISE). A TOTAL OF 189 PATIENTS (MEDIAN AGE, 68 YEARS; AGE RANGE, 41-88 YEARS; MALE-TO-FEMALE RATIO, 132/57) WITH 209 INTRACRANIAL ATHEROSCLEROTIC LESIONS WERE ENROLLED AND TREATED IN THE REGISTRY. LOT, MODEL AND/OR CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENTERPRISE STENT CONCOMITANT CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: RAPIDTRANSIT MICROCATHETER, PROWLER SELECT PLUS MICROCATHETER CONCOMITANT NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: (1) DELAYE

  Patient problems: Restenosis

  MAUDE report 13077628 ↗
• MalfunctionSep 10, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED DURING A NON-ACUTE RECANALIZATION OF INTRACRANIAL LARGE VESSEL OCCLUSION, ANGIOGRAPHY CONFIRMED SEVERE STENOSIS IN THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY. AFTER BALLOON DILATION, STENT-ASSISTED ANGIOPLASTY WAS PERFORMED USING THE 4.5MM X 14MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC451400 / 6216426). IT WAS REPORTED THAT THE STENT COULD NOT ADVANCE WITHIN THE MICROCATHETER WHEN IT ARRIVED AT THE PROXIMAL END OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO ADJUST BUT WAS NOT SUCCESSFUL. THE STENT WAS WITHDRAWN FROM THE PATIENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION AS A RESULT OF THE REPORTED ISSUE. THE COMPLAINT DEVICE WAS RETURNED WITH A PROWLER SELECT MICROCATHETER (CATALOG AND LOT NUMBER UNKNOWN). BASED ON THE FOLLOW-UP RESPONSE FROM THE AFFILIATE RECEIVED ON (B)(6) 2021, THE MICROCATHETER WAS USED IN THE SAME PROCEDURE; IT WAS USED WITH THE 4.5MM X 14MM NO DISTAL TIP ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE. WHEN THE STENT WAS IMPEDED IN THE MICROCATHETER DURING THE PROCEDURE, THE PHYSICIAN REMOVED IT TOGETHER WITH THE STENT RESULTIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457470 ↗
• MalfunctionJan 25, 2021Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING STENT THERAPY FOR INTRACRANIAL ARTERY STENOSIS, A 4.5MMD 14MML ENTERPRISE STENT DELIVERY SYSTEM WITHOUT DISTAL TIP (ENC451400, 11195605) COULDN'T MOVE FORWARD OR BACKWARD WITHIN A REBAR18 SIZE: 0.021 MICROCATHETER (MC). THE PHYSICIAN REMOVED THE STENT SYSTEM AND MICROCATHETER TOGETHER OUTSIDE OF THE PATIENT. THE STENT DEPLOYED OUTSIDE OF THE PATIENT¿S BODY. THE PHYSICIAN SWITCHED TO ANOTHER NEW STENT SYSTEM (SAME CODE AS THE COMPLAINT PRODUCT) AND A NEW MICROCATHETER, A PROWLER SELECT PLUS 150/5CM (606S255X, LOT UNKNOWN) TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11222328 ↗
• InjuryNov 16, 2020Premature Activation; Premature Activation

  A REPORT FROM THE FIELD INDICATED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION, A 4.5MM X 14MM ENTERPRISE NO DISTAL TIP (ENC451400/11174351) STENT PREMATURELY DEPLOYED IN THE BLOOD VESSEL. THE PHYSICIAN USED A STENT RETRIEVER TO REMOVE THE PROBLEM STENT FROM THE PATIENT AND ANOTHER SAME-SIZED ENTERPRISE STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT DEVICE WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 05-NOV-2020 INDICATED THAT A PROWLER SELECT PLUS MICROCATHETER (606SR55X/UNKNOWN LOT #) WAS USED IN CONJUNCTION WITH THE ENTERPRISE STENT. A SOLITAIRE (MEDTRONIC) STENT RETRIEVER WAS USED TO REMOVE THE PREMATURELY DEPLOYED ENTERPRISE STENT FROM THE PATIENT. THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED. IT WAS REPORTED THAT THE DEVICES WERE USED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN HAS 10+ YEARS OF EXPERIENCE. EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. THERE WAS AN ADEQUATE FLUSH MAINTAINED THROUGH THE DEVICES. THE EVENT RESULTED IN A 40-MINUTE PROCEDURAL DELAY, BUT THE PHYSICIAN DID NOT FEEL THAT THE DELAY W

  Patient problems: No Code Available

  MAUDE report 10842873 ↗