Z-2280-2019Class II

GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm)

Name: Z-2280-2019 GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm)
Creator: Codman & Shurtleff Inc
Published: 2019-05-16
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2019-05-16 / Terminated / root cause: labeling and UDI

FDA source

Codman & Shurtleff Inc began a recall of GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm) on 2019-05-16. FDA classified it as Class II and gives the reason as "Incorrect coil length on the label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2280-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-16
Posted: 2019-08-15
Terminated: 2020-06-04
Recalling firm: Cerenovus, Inc.
Product: GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).
Product code: HCG Device, Neurovascular Embolization
Reason for recall: Incorrect coil length on the label
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 28 units
Distribution: Japan
Product codes and lots: Lot/Serial No: L14364 UDI:10886704080138

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2280-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2280-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-21	2019-08-15

Product code HCG

K171862Class IIGALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc. / cleared 2017-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)