ORBIT GALAXY 640CF1030Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704030416), received between Dec 14, 2021 and Jan 13, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE, THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515/31613390) ENCOUNTERED A LOT OF RESISTANCE AND BECAME BENT AND THE DELIVERY WIRE ¿GOT BROKEN.¿ IT WAS ALSO REPORTED THAT THE 10MM X 30CM ORBIT GALAXY COMPLEX FILL COIL (640CF1030/31467308) ENCOUNTERED RESISTANCE DURING THE COIL ADVANCEMENT. THE 132CM EMBOVAC 71 ASPIRATION CATHETER (IC71132CA/31411520) GOT STUCK IN THE HOOP. THE PROCEDURE WAS DELAYED BY 15 MINUTES. IT WAS SUCCESSFULLY COMPLETED BY USING ¿ANOTHER CATHETER AND COILS.¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. BASED ON THE EVENT DESCRIPTION, THE ISSUE REPORTED WITH THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515/31613390) MEETS USFDA REPORTING CRITERIA A CLASSIFICATION OF ¿MALFUNCTION.¿ THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 09-JAN-2026, THE REPORTED ISSUE RELATED TO THE 10MM X 30CM ORBIT GALAXY COMPLEX FILL COIL (640CF1030/31467308) MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063816 ↗
• MalfunctionMar 18, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, AN ORBIT GALAXY COIL (640CF1030, 31039309) WAS FILLED IN ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED TO A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER (OTHER BRAND) WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921663 ↗
• InjuryJul 11, 2023Migration; Premature Separation; Migration; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A 10MM RIGHT INTERNAL CAROTID ARTERY (ICA) TERMINAL ANEURYSM THAT COMMENCED AT 09:00 AM ON (B)(6) 2023, A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 31007920) WAS PLACED AT THE TARGET LOCATION. THE COMPLAINT DEVICE, A 4MM X 23MM ENTERPRISE 2 STENT (ENCR402312 / 7469249) WAS IMPEDED IN THE DISTAL END OF THE MICROCATHETER AND COULD NOT PASS THROUGH; AFTER SEVERAL ATTEMPTS, IT STILL FAILED. THE PHYSICIAN RETRACTED THE STENT AND SWITCHED TO A NEW STENT, A 4MM X 30MM ENTERPRISE 2 STENT (ENCR403012 / 7442514) AND ENCOUNTERED THE SAME ISSUE. THE PHYSICIAN REPLACED THE MICROCATHETER WITH ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 30954486) AND RE-DELIVERED THE SECOND STENT (4MM X 30MM ENTERPRISE 2 STENT (ENCR403012)), AND THE STENT WAS STILL IMPEDED IN THE MICROCATHETER AT THE SAME LOCATION. THE PHYSICIAN REPLACED THE MICROCATHETER AGAIN USING ANOTHER 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT# UNKNOWN), HOWEVER, THE STENT WAS STILL UNABLE TO PASS THROUGH THE MICROCATHETER. IT WAS THEN REPORTED THAT DURING THE PROCESS OF FI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17303020 ↗
• MalfunctionJun 5, 2023Stretched; Difficult to Advance; Stretched; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THERE WAS RESISTANCE WHILE ADVANCING THE COMPLAINT COIL, A 10MM X 30CM ORBIT GALAXY COMPLEX FILL COIL (640CF1030 / 30921950) IN THE MICROCATHETER (UNSPECIFIED BRAND). WHEN THE COIL WAS REMOVED, IT WAS STRETCHED. THE REPORTED ISSUE RESULTED IN A 5-MINUTE PROCEDURE DELAY. THE COMPLAINT COIL WAS REMOVED. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO NEGATIVE PATIENT IMPACT. ON 25-MAY-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS TARGETING A 12MM X 10MM LOBULATED BIFURCATED ANEURYSM ON THE ANTERIOR COMMUNICATING ARTERY (ACOM). NO NECK REMODELING WAS USED. THE MICROCATHETER USED WAS AN ECHELON¿ 10 MICROCATHETER (MEDTRONIC). CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN THE TARGET SITE WAS BEING ACCESSED. THE RESISTANCE WAS FELT DURING THE ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER AT MID-SHAFT OF THE MICROCATHETER. THE INFORMATION INDICATED THAT AFTER THE ISSUE ENCOUNTERED WITH THE COMPLAINT COIL, FOUR (4) MORE COILS WERE DEPLOYED TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17062038 ↗
• MalfunctionJul 1, 2022Material Separation; Failure to Advance; Material Separation; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING AN APPROXIMATE 13MM X 12MM GIANT ANEURYSM NEAR THE C6 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA), AFTER DELIVERING THE FIRST COIL VIA THE SL-10® MICROCATHETER (STRYKER), THE PHYSICIAN TRIED TO FILL THE ANEURYSM WITH ANOTHER COIL, A 10MM X 30CM ORBIT GALAXY COMPLEX FILL COIL (640CF1030 / 30679275) AND PUSHED IT INTO THE Y CONNECTOR. IT WAS FOUND THAT THE COIL WAS IMPEDED IN THE PROXIMAL SECTION OF THE MICROCATHETER (THE COIL HAS NOT PASSED THROUGH THE Y CONNECTOR) AND COULD NO LONGER BE ADVANCED. THE PHYSICIAN APPLIED SOME FORCE, AND AT THIS MOMENT, THE DELIVERY TUBE OF THE COIL BROKE INTO TWO (2) PIECES. THE PHYSICIAN RETRACTED THE DAMAGED COIL AND SWITCHED TO A NEW COIL, A 7MM X 25CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0725 / 30628880), BUT IT WAS IMPEDED IN THE PROXIMAL SECTION OF THE MICROCATHETER AND COULD NO LONGER BE ADVANCED. THE PHYSICIAN WITHDREW THE COIL, FELT SOME RESISTANCE, AND FOUND THE DELIVERY TUBE KINKED / BENT. ANOTHER 7MM X 25CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0725 / 30532540) WAS USED AND THE SAME ISSUE WAS ENCOUNTERED; THE COIL WAS IMPEDED IN THE MIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14893494 ↗
• MalfunctionDec 14, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TARGETING A WIDE NECK BASILAR TOP ANEURYSM, BOTH COILS, A 10MM X 30CM ORBIT GALAXY COMPLEX FILL COIL (640CF1030 / 30305849) AND A 8MM X 30CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0830 / 30334344) COULD NOT BE RESHEATHED. THE COILS WERE REMOVED AND REPLACED. THE REPORTED ISSUE RESULTED IN A 15-MINUTE PROCEDURE DELAY, BUT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A GOOD PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE MICROCATHETER USED WAS A 150CMX5CM, 2 MARKERS, 45TIP PROWLER SELECT LPES FROM LOT 30342894. THERE WAS CONTINUOUS FLUSH MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO DAMAGE NOTED TO THE SHEATH INTRODUCERS. THERE WAS NO REPORT OF ANY RESISTANCE AT ANY TIME DURING THE ADVANCEMENT OF THE COILS THROUGH THE MICROCATHETER. THE PROCEDURE ALSO EMPLOYED A 4MM X 39MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE. THE CONCOMITANT MICROCATHETER WAS NOT REPOSITIONED OVER THE COIL WHEN THE CIL WAS DEPLOYED. THERE WAS A ONE-TO-ONE RELATIONSHIP BETWEEN THE COIL AND THE DELIVERY SYSTEM AND IT WAS VERIFIED WITH FLUOROSCOPY PRIOR TO REPOSITIONING. THE MICRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006718 ↗