ORBIT GALAXY ENPOWER XTRASOFT 641CX3505Recalls & reported problems
Medos International Sàrl · ORBIT GALAXY G2 microcoil Stretch Resistant Complex XTRASOFT Coil 3.5mm x 5cm 190cm Contents: 1 Detachable Coil System Coil Type: Stretch Resistant Complex XTRASOFT Coil · Class 2 · Implant
All models of ORBIT GALAXY ENPOWER XTRASOFT (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10878528008962), received between Jul 28, 2021 and Jul 28, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Stretched” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2021Stretched; Stretched
AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY (MCA), BIFURCATION ANEURYSM, A 3.5X5 ORBIT GALAXY ENPOWER XTRASOFT COIR (641CX3505, L14031) BECAME STRETCHED DURING THE DEPLOYMENT. THE PHYSICIAN REMOVED THAT COIL AND PLACED ANOTHER COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND NO PATIENT INJURY WAS REPORTED. THE SURGERY WAS DELAYED BY FIVE MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12239270 ↗
Other DEVICE, NEUROVASCULAR EMBOLIZATION devices
- POD RBYPODJ60-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION355 reports
- Penumbra System SCH1Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION295 reports
- RUBY Coil RBY4C0860-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION276 reports
- Smart Coil 400SMTHXSFT0208Penumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION165 reports
- Penumbra System RH1-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION154 reports
- Optima Coil System OPTI0208CSS10Balt USA LLC · Device, Neurovascular Embolization3 recalls3 reports
- POD RBYPOD6-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION148 reports
- POD RBYPODJ30-APenumbra, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION132 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page