ORBIT GALAXY ENPOWER 641CF3575Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10878528009495), received between Jun 2, 2020 and Apr 4, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2025Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212 / 8582189) WAS IMPEDED IN THE PROXIMAL SECTION OF THE CONCOMITANT MICROCATHETER (UNSPECIFIED BRAND) AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN RETRACTED ONLY THE STENT AND FOUND THAT IT HAD DETACHED FROM THE DELIVERY WIRE IN THE INTRODUCER. THE PHYSICIAN REPLACED THE STENT TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21776042 ↗
• MalfunctionOct 21, 2024Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY, THE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452212 / 8878724) WAS IMPEDED IN THE PROXIMAL AREA OF THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31342751) AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT AND REPLACED BOTH DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 14-OCT-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE ADDITIONAL INFORMATION CONFIRMED THE PROCEDURE WAS A STENT-ASSISTED EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. WHEN THE STENT WAS REMOVED FROM THE PATIENT, IT WAS NO LONGER STILL ON THE DELIVERY WIRE. THE REPLACEMENT STENT WAS ANOTHER 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (ENC452212) AND THE REPLACEMENT MICROCATHETER WAS ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). THE ADDITIONAL INFORMATION CONFIRMED THERE WAS NO NEGATIVE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20500683 ↗
• MalfunctionAug 5, 2024Material Separation; Material Separation

  AS REPORTED BY THE FIELD, DURING A ENDOVASCULAR EMBOLIZATION, AT THE TIME OF DELIVERING AN EU 4.5X22MM STENT 12 MM DW TIP INTRACRANIAL STENT (ENC452212, 8697557) IN A PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, LOT UNKNOWN), THE FORCE (TO DELIVER THE STENT) FELT BY THE PHYSICIAN REDUCED SUDDENLY. THE PHYSICIAN REMOVED THE STENT AND MICROCATHETER (MC) FROM THE PATIENT AND OBSERVED THE DELIVERY WIRE BROKE AND THE REST OF THE STENT WAS REMAINED IN THE MICROCATHETER. THE PHYSICIAN REMOVED THE REST OF THE STENT FROM THE MICROCATHETER WITH OTHER DEVICES. AND THEN THE SAME MICROCATHETER WAS USED TO DELIVER A NEW STENT TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 30-JUL-2024 INDICATED THAT THERE WAS NO EVIDENCE OF FRAGMENTS REMAINING IN THE PATIENT. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. THE DEVICE WAS EXAMINED PRIOR TO USE. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906406 ↗
• MalfunctionSep 11, 2022Break; Failure to Advance; Break; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 22MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452212 / 7044261) WAS IMPEDED IN THE MICROCATHETER AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN RETRACTED THE STENT AND OBSERVED THAT THE STENT BODY WAS DEFORMED. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE; THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 06-SEP-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA). THE MICROCATHETER USED WAS A 150/5CM PROWLER SELECT PLUS (606S255X / 30772057). CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. DURING THE PROCEDURE THE STENT WAS IMPEDED IN THE MICROCATHETER AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN RETRACTED THE STENT AND FOUND THE STENT BODY WAS DEFORMED. DETAILS ON THE REPORTED DAMAGE / DEFORMATION WAS NOT PROVIDED. THE STENT COMPONENT WAS REPORTED TO STILL BE ATTACHED TO THE DELIVERY WIRE WHEN IT WAS REMOVED FROM THE PATIENT. THERE WAS NO DAMAGE NOTED ON THE MICROCATHETER. THE REPLACEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15398152 ↗
• MalfunctionJun 6, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST EMBOLIZATION, A 4.5X22MM ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT (ENC452212, LOT UNKNOWN) BECAME IMPEDED IN THE UNSPECIFIED MICROCATHETER (MC) AND COULD NOT ADVANCE ANYMORE. THE PHYSICIAN TRIED TO WITHDRAW THE STENT BUT FELT RESISTANCE AND IT COULD NOT BE RETRACTED. THEN DOCTOR REMOVED THE STENT WITH THE MICROCATHETER TOGETHER AND SWITCHED TO A NEW STENT TO COMPLETE THE SURGERY (THE MICROCATHETER WAS NOT REPLACED AND IT WAS IN GOOD CONDITION). THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14602923 ↗
• MalfunctionMay 19, 2022Material Separation; Failure to Advance; Material Separation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING STENT-ASSIST COIL EMBOLIZATION, A 4.5 X 22MM ENTERPRISE STENT 12 MM DW TIP (ENC452212, 6812660) BECAME IMPEDED IN THE INTRODUCER SHEATH AND COULD NOT BE PUSHED OUT. THE PHYSICIAN ADJUSTED THE STENT, BUT THE DELIVERY WIRE BROKE INTO 2 PIECES. THE STENT WAS NOT USED IN THE PATIENT, THEREFORE THERE WAS NO PATIENT INJURY. A NEW DEVICE WAS CHANGED TO COMPLETE THE SURGERY. PICTURES HAVE BEEN PROVIDED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434686 ↗
• MalfunctionMar 23, 2022Activation Problem; Activation Problem

  AS REPORTED BY THE FIELD, DURING A STENT ASSIST EMBOLIZATION, A 4.5X22MM ENTERPRISE INTRACRANIAL NEUROVASCULAR STENT 12MM DW TIP (ENC452212, 6610122) PASSED THROUGH THE PROWLER SELECT PLUS MICROCATHETER (606S255X, 30452037). THE PHYSICIAN TRIED TO RELEASE THE STENT, BUT IT COULD NOT BE OPENED, THE PHYSICIAN RETRACTED THE STENT A LITTLE FOR ADJUSTING AND INTENDED TO OPEN THE STENT AGAIN, BUT STILL FAILED. THE ENTERPRISE WAS RECAPTURED INTO THE MICROCATHETER AND REMOVED. A NEW STENT WAS SWITCHED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE HAD NOT BEEN ANY RESISTANCE DURING ADVANCEMENT OF THE DEVICE. THE STENT DID NOT APPEAR DAMAGED. THERE WERE NO VESSEL OR ANEURYSM FACTORS THAT CONTRIBUTED TO THE INCOMPLETE EXPANSION. THERE WAS NO BLOOD FLOW RESTRICTION. AN ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THERE WAS NO PROLONGATION IN THE PROCEDURE DUE TO THE EVENT. THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE STENT WAS FOUND BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13869218 ↗
• MalfunctionFeb 3, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED EMBOLIZATION OF ANEURYSM, A 4.5X22MM ENTERPRISE INTRACRANIAL STENT 12MM DW TIP (ENC452212, 6357990) IMPEDED IN INTRODUCER. IT WAS REPORTED THAT BEFORE THE PROCEDURE, THE PHYSICIAN OPENED THE PACKAGE, OBSERVED STENT WAS IMPEDED IN INTRODUCER AND COULD NOT BE PUSHED OUT, IT WAS NOT USED ON THE PATIENT. THE PHYSICIAN SWITCHED TO ANOTHER NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THEY WERE NOT ABLE TO MOVE THE DEVICE AT ALL DUE TO THE RESISTANCE. NOTHING WAS NOTED TO BE OBSTRUCTING THE INTRODUCER SHEATH. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE STENT WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13440518 ↗
• MalfunctionDec 16, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING THE PROCEDURE, A 4.5X22MM ENTERPRISE STENT (ENC452212, 6259379) BECAME IMPEDED IN THE TIP OF A 150/5CM PROWLER SELECT PLUS MICROCATHETER (606S255X, 30529197) AND COULD NOT BE ADVANCED OR RETRACTED. THE PHYSICIAN REMOVED THE STENT FROM THE PATIENT WITH THE MICROCATHETER (MC) TOGETHER. A COMPETITOR¿S STENT AND MICROCATHETER WERE USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018334 ↗
• MalfunctionJun 24, 2021Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT ASSISTED COIL EMBOLIZATION FOR ANEURYSMS, A 4.5X22MM (ENC452212, 5852782) COULDN'T CROSS THROUGH THE UNSPECIFIED MICROCATHETER (MC). THE PHYSICIAN TRIED TO WITHDRAW THE STENT BUT FAILED AND THE STENT WAS DETACHED IN MICROCATHETER WITHOUT EXPECTATION. THE PHYSICIAN REMOVED THE MICROCATHETER AND THE STENT DELIVERY SYSTEM OUTSIDE OF THE PATIENT. THE PHYSICIAN SWITCHED TO ANOTHER NEW MC AND A NEW STENT DELIVERY SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NOT PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12057838 ↗
• MalfunctionApr 20, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT-ASSISTED ANEURYSM EMBOLIZATION, A 4.5X22MM ENTERPRISE STENT DELIVERY SYSTEM 12 MM DW TIP (ENC452212, 6117573) IMPEDED. THE STENT COULDN¿T ADVANCE IN THE 150/5CM PROWLER SELECT PLUS MICROCATHETER (606S255X, 30224716). THE MICROCATHETER WAS FOUND BENT. THE PHYSICIAN REMOVED BOTH DEVICES TOGETHER AND CHANGED TO NEW ONES. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692735 ↗
• MalfunctionOct 20, 2020Failure to Advance; Material Twisted/Bent; Failure to Advance; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A STENTING PROCEDURE, A 4.5X22MM ENTERPRISE STENT DELIVERY SYSTEM (ENC452212, 11195601) BECAME IMPEDED IN THE 150/5CM PROWLER SELECT PLUS MICROCATHETER (606S255X, 30302819). IT WAS REPORTED THAT THE PHYSICIAN FOUND THE STENT BODY IMPEDING IN MICROCATHETER (MC), THEN HE PULLED BACK THE STENT SYSTEM AND MICROCATHETER OUTSIDE OF THE PATIENT. HE FOUND THE PROXIMAL END OF STENT BODY AND DISTAL END OF DELIVERY WIRE WERE ¿WRINKLED UP¿. THE PROXIMAL END OF THE MC HUB WAS WRINKLED TOO. THE PROCEDURE WAS COMPLETED BY A NEW STENT SYSTEM AND MICROCATHETER. THERE WAS NO PATIENT INJURY REPORTED. BEFORE THE STENT ENTERED THE MICROCATHETER, THE STENT CONNECTED WITH THE MICROCATHETER¿S HUB CLOSELY. THE Y CONNECTOR WAS CLOSE TIGHTLY AS WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10705153 ↗
• MalfunctionJun 9, 2020Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ANTERIOR COMMUNICATING ANEURYSM EMBOLIZATION, A 4.5X22MM ENTERPRISE DELIVERY SYSTEM (ENC452212, 11140855) WAS STUCK IN A 150/5CM PROWLER SELECT PLUS MICROCATHETER 606S255X, 30306198). IT WAS REPORTED THAT THE STENT COULDN'T BE PUSHED OR WITHDRAWN IN THE MICROCATHETER AFTER A NO SPECIFIED COIL ARRIVED AT THE TARGET POSITION THROUGH THE SAME MICROCATHETER (MC). THEN THE PHYSICIAN WITHDREW THE STENT AND MICROCATHETER TOGETHER OUTSIDE OF THE PATIENT. THE PHYSICIAN CHANGED TO ANOTHER NEW MICROCATHETER AND STENT WITH SAME PRODUCT CODE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORT. THE TARGET CEREBRAL POSITION WAS LOST. THE TARGET POSITION IS AN A2 BLOOD VESSEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10134460 ↗
• MalfunctionJun 2, 2020Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A STENT IMPLANTATION FOR INTRACRANIAL ARTERY STENOSIS, A 4.5X22 MM ENTERPRISE STENT DELIVERY SYSTEM WAS IMPEDED IN A NONSPECIFIC MICROCATHETER. THE MICROCATHETER (MC). IT WAS REPORTED BY PHYSICIAN THAT THE STENT COULDN'T BE PUSHED IN THE MICROCATHETER. THE PHYSICIAN WITHDREW THE STENT, BUT IT DEPLOYED IN THE MC. THEN THE PHYSICIAN WITHDREW THE STENT AND MICROCATHETER OUTSIDE OF THE BODY TOGETHER. CHANGED TO A NEW STENT TO COMPLETE THE PROCEDURE. THE TARGET CEREBRAL POSITION WAS LOST. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10108839 ↗