ORBIT GALAXY ENPOWER 641CF0925Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10878528009648), received between Dec 6, 2016 and Dec 16, 2020 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2020Premature Activation; Premature Activation

  AS REPORTED BY THE FIELD, DURING A SURGICAL PROCEDURE FOR THE COMMUNICATING ANEURYSM, CATHETERIZATION OF THE RIGHT A2 SEGMENT USING A PROWLER MICROCATHETER (MC) AND A TERUMO 16'-90 °WAS USED. WHEN DEPLOYMENT OF THE INTRACRANIAL, THE STENTS OF TWO 4MMX23MM ENTERPRISE2 NO TIP (ENC402300, 11193908) AND (ENC402300, 5711204) GOT RELEASED INSIDE THE CATHETER AND SO IT WAS NOT POSSIBLE TO RECAPTURE THEM ANYMORE. A THIRD ENTERPRISE STENT DELIVERY SYSTEM (ENC403012, 1161318) WAS USED WITH SUCCESS. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATION FOR THE PATIENT. THE PATIENT HAD A SCANNER AND MRI AS PART OF A HEADACHE ASSESSMENT ASSOCIATED WITH A PHASIC DISORDER THAT HAD BEEN EVOLVING FOR SEVERAL WEEKS. THE IMAGES SHOW A GIANT ANEURYSM PARTIALLY THROMBOSED OF THE LEFT SYLVIC BIFURCATION, RESPONSIBLE FOR A LEFT FRONTOTEMPORAL PERI-LESIONAL EDEMA EXPLAINING THE SEMIOLOGY. IT WAS ALSO FORTUITOUSLY EVIDENCED AN ANEURYSM OF THE ANTERIOR COMMUNICATING COMPLEX OF ABOUT 10 MM. ON (B)(6) 2020, THE PATIENT UNDERWENT A TEMPORO-SYLVIC BYPASS BY ANASTOMOSIS BETWEEN THE LEFT SUPERFICIAL ARTERY AND THE TEMPORAL BRANCH OF THE LEFT MIDDLE CEREBRAL ARTERY ALLOWING THE EXCLUSION OF THE GIANT ANEURYSM BY CL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11019379 ↗
• MalfunctionJun 16, 2020Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  AS REPORTED BY THE FIELD, A 150/5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX, 30299292) WAS DELIVERED TO THE LESION. THEN A 4MMX23MM ENTERPRISE2 STENT DELIVERY SYSTEM (ENC402300, 11157431) WAS INSERTED INTO THE MICROCATHETER (MC) BUT THERE WAS A STRONG RESISTANCE FELT AND IT WAS NOT ABLE TO ADVANCE THROUGH THE MC. THE STENT OF THE ENTERPRISE2 DID NOT DEPLOY INSIDE THE PATIENT. THEY WERE REPLACED WITH ANOTHER PROWLER SELECT PLUS AND ENTERPRISE 2. THE ENTERPRISE 2 WAS IMPLANTED WITHOUT ANY PROBLEMS. THE PROCEDURE COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. IT IS UNCLEAR WHICH PART OF THE MICROCATHETER THE RESISTANCE OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE COMPLAINT STENT WAS INSERTED INTO THE COMPLAINT MICROCATHETER TO IMPLANT THE COMPLAINT STENT. THE MICROCATHETER CAME OUT FROM THE LESION. THE PHYSICIAN ATTEMPTED TO RE-SHEATH THE COMPLAINT STENT AS PER THE INSTRUCTIONS FOR USE (IFU) BUT IT WAS IMPLANTED INSIDE THE COMPLAINT MICROCATHETER AND THE STENT WAS NOT ABLE TO BE RE-SHEATHED. THE PHYSICIAN REQUESTED THE INVESTIGATION OF THE DISTAL DELIVERY WIRE WHICH HAD STENT PART. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PICTURES W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10157567 ↗
• MalfunctionJun 15, 2020Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, A 4MMX23MM ENTERPRISE2 STENT DELIVERY SYSTEM (ENC402300, 11004261) WAS INSERTED INTO A 150/5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX, 17745485) BUT THERE WAS A STRONG RESISTANCE FELT AND IT WAS NOT ABLE TO ADVANCE THROUGH THE MICROCATHETER (MC). IT OCCURRED WHEN THE STENT WAS APPROXIMATE 3 CM FROM THE DISTAL END OF THE MC. THE STENT DID NOT DEPLOY INSIDE THE PATIENT. THE DEVICES WERE REPLACED WITH ANOTHER PROWLER SELECT PLUS AND ENTERPRISE 2. THE ENTERPRISE 2 WAS IMPLANTED WITHOUT ANY PROBLEMS. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10153265 ↗
• MalfunctionApr 20, 2020Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A 4MMX23MM ENTERPRISE2 NO TIP STENT DELIVERY SYSTEM (ENC402300,10998144), WAS INSERTED INTO A CONCOMITANT MICROCATHETER, 150/5CM 45TIP PROWLER SEL PLUS (606S255FX, 30296214) BUT THERE WAS INTENSIVE RESISTANCE FELT AT 5CM FROM THE DISTAL TIP. IT WAS NOT ABLE TO BE ADVANCED ANYMORE. IT WAS REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PRE-SHIPMENT PICTURES OF THE PROWLER SELECT PLUS MICROCATHETER WERE RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9978341 ↗
• MalfunctionDec 17, 2018Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 9 MM X 25 CM GALAXY G2 COMPLEX FILL COIL (641CF0925 / L10099) COULD NOT BE DETACHED DURING THE PROCEDURE. THE COIL WAS REPLACED. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8169567 ↗
• MalfunctionApr 18, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING THE PROCEDURE THE PHYSICIAN WAS UNABLE TO DETACH A GALAXY G2 9X25 COIL. THE PHYSICIAN PLACED THE G2 COIL INTO THE ANEURYSM WITHOUT ANY PROBLEM. HOWEVER, WHEN ATTEMPTED TO DETACH, THE COIL WOULD NOT DETACH. THE COIL WAS REPOSITIONED MULTIPLE TIMES AND DETACHMENT WAS ATTEMPTED EACH TIME, THE COIL NEVER DETACHED. IT WAS REMOVED FROM THE ANEURYSM AND A SECOND GALAXY G2 9X25 WAS THEN PLACED AND DETACHED WITHOUT A PROBLEM. THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THE PRODUCT FAILURE. DUE TO ATTEMPTED OF DETACHMENT, REMOVAL AND REPLACEMENT OF THE G2 COIL THE SURGERY WAS DELAYED BY 5 MINUTES. THE COIL WAS NOT STRETCHED WHEN REMOVED AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED, THE SYSTEM GREEN READY LIGHT ILLUMINATED AND THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE. THE AUDIBLE SIGNAL HAD BEEPED AND ALL CONNECTIONS FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE SAME CONNECTING CABLE AND DCB WAS USED SUCCESSFULLY WITH REST OF THE COILS (G2) AND THERE WERE NO ISSUES. THE COMPLAINT DEVICE IS AVAILABLE FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6499750 ↗
• MalfunctionDec 6, 2016Stretched; Physical Resistance; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, A CASHMERE (SRC14102520/ C29062) COULD NOT BE ADVANCED THROUGH AN SL 10 MICROCATHETER, THE DISTAL END OF THE COIL WAS KINKED, AND THE SHEATH DISLODGED DURING RESHEATHING AND A GALAXY G2 (SRC14102520/ C29062) WAS DIFFICULT TO ADVANCED AND WAS FOUND TO BE STRETCHED UPON REMOVAL AND WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. INITIALLY, USING AN ENVOY DA AND SL10 MICROCATHETER, A HELIPAQ 10 X 30 WAS ADVANCED WITHOUT ISSUE. THE COMPLIANT CASHMERE 10 X 14 WOULD NOT BE ADVANCED INTO THE SL 10 MICROCATHETER AND WHEN REMOVED, THE DISTAL END WAS KINKED. WHEN ATTEMPTING TO RE-SHEATH THE COIL, THE SHEATH DISLODGED (THE WIRE CAME THROUGH THE SHEATH). A SYNCRO 2 WIRE WAS INTRODUCED TO CHECK FOR A KINK IN THE SYSTEM, BUT NO KINK WAS FOUND. NEXT A 9 X 25 GALAXY 2 COIL WAS INTRODUCED INTO THE MICROCATHETER AND THE LAST 8-10 INCHES WAS TOO DIFFICULT TO ADVANCED FURTHER. UPON TRYING TO REMOVE THE COIL, THE COIL STRETCHED INSIDE THE MICROCATHETER, AND BOTH WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR¿S COIL. IT WAS REPORTED THAT THERE WAS A 25 MINUTES DELAY TO SELEC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6147330 ↗