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ORBIT GALAXY 640CF0715Recalls & reported problems

Medos International Sàrl · ORBIT GALAXY Detachable Coil System with Tight Distal Loop technology 175cm d=2/3D D=7mm 15cm Contents: 1 detachable coil system and 1 luer valve. Coil Type: Complex Fill Note: ONLY use with TRUFILL DCS Syringe II. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704030355), received between Jun 6, 2022 and Jun 6, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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

Device problems

  • Deformation Due to Compressive Stress1

Patient problems

  • Aneurysm1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 6, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

    THE EVENT WAS REPORTED VIA THE STERLING STUDY, A 55-YEAR-OLD MALE PATIENT (SUBJECT (B)(6)) WITH A HISTORY OF CONTROLLED HYPERLIPIDAEMIA, HYPERTENSION, CURRENT SMOKER SUBARACHNOID HEMORRHAGE (SAH) (TARGET ANEURYSM) UNDERWENT COIL EMBOLIZATION OF A RUPTURED LEFT ANTERIOR COMMUNICATING ARTERY (ACOA) ANEURYSM WITH HUNT & HESS GRADE 1, MODIFIED RANKIN SCALE (MRS) SCORE 1 ON (B)(6) 2021. THE DIMENSION OF THE ANEURYSM WERE AS FOLLOWS: HEIGHT 6.4MM, DOME 6.5MM, MAXIMUM ANEURYSM DIAMETER 8.6MM, NECK SIZE 3.3MM, AND DOME-TO-NECK RATIO OF 2.0MM. THE PARENT VESSEL DIAMETER WAS 2.4MM. COIL EMBOLIZATION WAS PERFORMED WITH SIX (6) CERENOVUS COILS: A 4MM X 10CM ORBIT GALAXY COMPLEX FILL (640CF0410 / 30396173), A 3MM X 4CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0304 / 30393990), A 7MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0715 / 30422037), A 6MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0615 / 30396174), A 6MM X 15CM ORBIT GALAXY COMPLEX FILL (640CF0615 / 30451949), AND A 2MM X 2CM ORBIT GALAXY COMPLEX XTRASOFT (640CX0202 / 30432544) VIA A PROWLER SELECT PLUS MICROCATHETER. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY

    Patient problems: Aneurysm

    MAUDE report 14603868 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.