ORBIT GALAXY 640CF0721Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886704030362), received between Oct 10, 2017 and Sep 4, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Stretched” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 4, 2025Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 7MM X 21CM ORBIT GALAXY COMPLEX FILL COIL (640CF0721 / 31309286) WAS IMPEDED IN THE Y-CONNECTOR AND COULD NOT BE PUSHED INTO THE CONCOMITANT MICROCATHETER (COMPETITOR BRAND). THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT TO COMPLETE THE PROCEDURE USING THE SAME ORIGINAL MICROCATHETER. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. ON 25-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THERE WAS NO UNDUE PROCEDURAL DELAY DUE TO THE REPORTED ISSUE. THE DEVICE DID NOT APPEAR DAMAGED. NOTHING WAS OBSTRUCTING THE CONNECTOR, AND A CONTINUOUS FLUSH WAS MAINTAINED. THE INTRODUCER WAS ALSO FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBING. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE PRODUCT INVESTIGATION COMPLETED ON 04-SEP-2025, THE ISSUE REPORTED HAS BEEN DETERMINED TO BE REPORTABLE AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22973746 ↗
• MalfunctionJul 24, 2025Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A COIL EMBOLIZATION, A 7X21 ORBIT GALAXY COIL (640CF0721, LOT UNKNOWN) COULDN¿T BE ADVANCED NOR RETRIEVED BY THE PHYSICIAN. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND SEVERELY STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588611 ↗
• MalfunctionFeb 9, 2024Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION TO A LEFT POSTERIOR COMMUNICATING ARTERY ANEURYSM, THE PHYSICIAN FILLED THE ANEURYSM WITH AN ORBIT GALAXYCOIL (640CF0721, (B)(6)) AND FOUND THAT THE COIL WAS UNRAVELED/STRETCHED. THE PHYSICIAN RETRACTED THE COIL AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON (B)(6) 2024 INDICATED THAT AN ECHELON10 MICROCATHETER WAS USED. NO OTHER COILS WERE ADVANCED THROUGH THE SAME MICROCATHETER PRIOR TO THE RESISTANCE ENCOUNTERED. THERE WAS NO BLOOD FLOW RESTRICTION/REDUCTION AS A RESULT OF THE EVENT. THERE WAS MODERATE VASCULAR CALCIFICATION. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676681 ↗
• MalfunctionNov 8, 2023Positioning Problem; Positioning Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE INTERNAL CAROTID PARENT ARTERY, THE PHYSICIAN STARTED TO FILL AN ANEURYSM WITH AN ORBIT GALAXY 7X21 COIL AS THE FIRST COIL, HOWEVER, IT WAS DIFFICULT TO POSITION THE COIL IN TARGET SITE. THE COIL DID NOT CONFORM TO THE WALLS OF THE ANEURYSM. THE PHYSICIAN WITHDREW THE COIL INTO AN UNSPECIFIED MICROCATHETER (MC) AND TRIED TO FILL THE ANEURYSM AGAIN, BUT THE SAME ISSUE OCCURRED. THEN, THE COIL WAS RETRACTED AND SWITCHED TO A NEW COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THE PROCEDURE WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON 08-NOV-2023 INDICATED THAT THE COIL DID NOT APPEAR TO BE DAMAGE WHILE IN THE ANEURYSM WHICH MAY HAVE CONTRIBUTED TO THE POSITIONING DIFFICULTY. THERE WERE NO ANEURYSM CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE POSITIONING DIFFICULTY. THE 10-MINUTE SURGERY PROLONGATION WAS NOT CLINICALLY SIGNIFICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092176 ↗
• InjuryMay 12, 2023Retraction Problem; Material Separation; Positioning Problem; Migration; Retraction Problem; Material Separation; Positioning Problem; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 67-YEAR-OLD FEMALE PATIENT PRESENTED WITH A RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOA) ANEURYSM WITH SUBARACHNOID HEMORRHAGE (SAH) UNDERWENT A STENT-ASSISTED COIL EMBOLIZATION AT 1:00 PM IN THE AFTERNOON OF (B)(6)2023. DURING THE PROCEDURE, A 4MM X 23MM ENTERPRISE 2 STENT (ENCR402312 / 7469241) WAS PARTIALLY RELEASED AND THE FIRST COIL, A 7MM X 21CM ORBIT GALAXY COMPLEX FILL (640CF0721 / 30583732) WAS DELIVERED INTO THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 30984564) AND FILLED THE ANEURYSM. THE COIL SHAPE WAS FOUND TO BE UNSATISFACTORY. THE PHYSICIAN TRIED TO WITHDRAW THE COIL FOR ADJUSTMENT, BUT THE COIL COULD NOT BE RETRACTED. THE PHYSICIAN ATTEMPTED TO ADJUST, BUT THE COIL SUDDENLY DETACHED PREMATURELY WITH A PART OF THE COIL OUTSIDE THE ANEURYSM. A PART OF THE COIL WAS STILL ON THE COIL ¿ATTACHMENT POINT WHEN THE DELIVERY WIRE OF THE COIL WAS REMOVED FROM THE PATIENT¿S BODY.¿ THROMBOSIS WAS NOTED ON ANGIOGRAPHY, AND PHARMACOLOGICAL THROMBOLYSIS WAS ADMINISTERED. AFTER A FEW MINUTES OF OBSERVATION, THE PHYSICIAN FILLED THE ANEURYSM WITH FIVE (5) COILS AND THEN BEGAN TO RELEASE THE STENT. IT WAS FOUND THAT THE

  Patient problems: Paralysis; Thromboembolism

  MAUDE report 16924657 ↗
• InjuryJul 29, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  THE EVENT WAS REPORTED VIA THE (B)(6) STUDY, THE (B)(6) YEAR-OLD MALE PATIENT ((B)(6)) WITH NO RELEVANT MEDICAL HISTORY PRESENTED WITH A LEFT POSTERIOR CEREBRAL ARTERY FUSIFORM ANEURYSM (HUNT & HESS GRADE 1) AT THE INTERNAL CAROTID ARTERY ON (B)(6) 2020 AND SUBSEQUENTLY UNDERWENT A STENT-ASSISTED COIL EMBOLIZATION USING A 4MM X 16MM ENTERPRISE 2 (ENCR401600 / 5876388) VASCULAR RECONSTRUCTION DEVICE (VRD) ON (B)(6) 2020. THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: MAXIMUM ANEURYSM DIAMETER 4MM AND NECK SIZE 2MM. THE PARENT VESSEL DIAMETER WAS 2.5MM. THE STENT AND UNSPECIFIED COILS WERE SUCCESSFULLY PLACED IN THE ANEURYSM. IMMEDIATE POST-PROCEDURE ASSESSMENT SHOWED RAYMOND-ROY SCORE OF CLASS I: COMPLETE OBLITERATION. THERE WERE NO REPORTED INTRAOPERATIVE COMPLICATIONS OR STUDY DEVICE DEFICIENCIES. ROUTINE NEUROLOGICAL EXAMINATION PERFORMED PRIOR TO DISCHARGE ON (B)(6) 2020 REVEALED HUNT & HESS GRADE 0 (UNRUPTURED ANEURYSM) AND MODIFIED RANKIN SCALE (MRS) SCORE OF 0 (NO SYMPTOMS AT ALL). MODIFIED INFORMATION WAS RECEIVED ON 05 JUL 2021. THE INFORMATION INDICATED THAT THE PATIENT DEVELOPED AN INTRACRANIAL ANEURYSM ON (B)(6) 2021. THE ANEURYSM WAS CONSIDERED MODERATE IN SEVERITY AND REQU

  Patient problems: Aneurysm; Transient Ischemic Attack

  MAUDE report 12250073 ↗
• MalfunctionJul 17, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF THE RIGHT POSTERIOR COMMUNICATING ARTERY (PCOM), THE USER EXPERIENCED MAJOR RESISTANCE WHILE ADVANCING A 7X21 OG TDL CMPLX FILL (640CF0721, 17710989) AS THE SECOND COIL INTO THE SL-10 MICROCATHETER (MC). AT THIS POINT HE CHECK THE TIGHTNESS OF THE RHV ON THE SHUTTLE. HE REMOVED THE COIL AND INSPECTED THE COIL AND THE DELIVERY TUBE AND NOTHING SEEMED UNUSUAL. THEN A 7X21 OG TDL CMPLX FILL COIL (640CF0721, 17722907) WAS IMPLANTED NORMALLY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO LOSS OF CEREBRAL TARGET POSITION. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE SURGERY WAS DELAYED THREE TO FOUR MINUTES. A 6F COOK SHUTTLE WAS USED. THE SL-10 MC WAS JAILED IN THE ANEURYSM BY THE ENTERPRISE STENT. THE VESSELS WERE NOT TORTUOUS AND CERTAINLY NOT CALCIFIED. AN 8X15 ORBIT GALAXY COMPLEX FILL WAS USED AS THE FIRST COIL. IT WAS REPORTED THAT THE DEVICES¿ LOOKED INTACT PRIOR TO PLACEMENT, DURING PLACEMENT AND AFTER REMOVAL¿. WHEN THE DEVICES WERE REMOVED FROM THE PATIENT, THERE WERE NO DAMAGES ON ANY PART OF THE DEVICES. BASED ON THE DEVICE INVESTIGATION, THE EMBOLIC COIL WAS STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800171 ↗
• MalfunctionNov 7, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE ORBIT GALAXY COMPLEX FILL 7MM X 21CM COIL (640CF0721 / LO# NOT AVAILABLE) WAS NOT SECURELY PACKAGED AND THE DEVICE FELL OUT. THE PHYSICIAN REPLACED THE COIL WITH ANOTHER ORBIT GALAXY AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY REPORT OF PATIENT CONSEQUENCE OR ADVERSE EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8048140 ↗
• MalfunctionOct 10, 2017Stretched; Physical Resistance; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A PHYSICIAN PULLED THE COIL ORBIT GALAXY (640CF0721/ 17524241) AND UNSPECIFIED MICROCATHETER AT THE SAME TIME. AFTER INSPECTION, IT WAS DISCOVERED THAT THE COIL WAS STRETCHED. THERE WERE NO POTENTIAL ADVERSE EVENTS, AND IT WAS REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6938338 ↗