GALAXY G3 recallZ-2280-2019 · Codman & Shurtleff Inc · initiated May 16, 2019
Class II Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Codman & Shurtleff Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect coil length on the label
FDA root cause category: Error in labeling
What the company is doing
Sales representatives will communicate the action to be taken with respect to this recall. If you have additional questions about this action, please contact y0ur local customer service.
Recall details
- Recall number
- Z-2280-2019
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 16, 2019
- Recalling firm
- Codman & Shurtleff Inc
- Quantity
- 28 units
- Product code
- HCG
- FDA submissions
- K171862
- Distribution
- Japan
Product description
GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
Code information (models, lots, serial numbers)
Lot/Serial No: L14364 UDI:10886704080138
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- GALAXY G3 GLM915020Cerenovus, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION1 recall44 reports
Product lines
Other devices under the same FDA submission
18 devices cleared under K171862 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- GALAXY G3 GLM920060Cerenovus, Inc. · Device, Vascular, for Promoting Embolization89 reports
- GALAXY G3 GLM910030Cerenovus, Inc. · Device, Vascular, for Promoting Embolization79 reports
- GALAXY G3 GLM910040Cerenovus, Inc. · Device, Vascular, for Promoting Embolization77 reports
- GALAXY G3 GLM910020Cerenovus, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION67 reports
- GALAXY G3 GLM915030Cerenovus, Inc. · Device, Vascular, for Promoting Embolization51 reports
- GALAXY G3 GLM920030Cerenovus, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION48 reports
- GALAXY G3 GLM920040Cerenovus, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION47 reports
- GALAXY G3 GLM915040Cerenovus, Inc. · DEVICE, NEUROVASCULAR EMBOLIZATION40 reports
- GALAXY G3 GLM930060Cerenovus, Inc. · Device, Vascular, for Promoting Embolization1 death32 reports
- GALAXY G3 GLM910010Cerenovus, Inc. · Device, Vascular, for Promoting Embolization26 reports
- GALAXY G3 GLM925045Cerenovus, Inc. · Device, Vascular, for Promoting Embolization23 reports
- GALAXY G3 GLM930080Cerenovus, Inc. · Device, Vascular, for Promoting Embolization17 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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