Food, drugs, devices › Codman & Shurtleff Inc

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

FDA enforcement event 83502 · Class II · initiated 16 May 2019 · status Terminated · terminated 4 Jun 2020

DeviceVoluntary: Firm initiated1 product recordFremont, CA

FDA enforcement event 83502 is a device recall by Codman & Shurtleff Inc of Fremont, CA, initiated 16 May 2019 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 4 Jun 2020. Initiation: voluntary: firm initiated. Codman & Shurtleff Inc has 11 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Codman & Shurtleff Inc, Fremont, CA.

Reason for recall

"Incorrect coil length on the label"

Distribution

"Japan"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2280-2019	GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).	28 units	Class II	Terminated	21 Aug 2019

Context

88%of 2019 device events are Class II968 events that year

1product record in this eventfirm median: 2

11events on this register for the firm

Other enforcement events for Codman & Shurtleff Inc

Initiated	Product (first record)	Type	Class	Records
10 Nov 2015	MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the i	Device	Class II	2
5 Mar 2015	CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable	Device	Class II	1
15 Sep 2014	Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for	Device	Class II	3
3 Jul 2014	Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device	Device	Class II	8
13 Dec 2013	CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 I	Device	Class II	1
11 Oct 2013	TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil a	Device	Class I	2
13 Aug 2013	MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrath	Device	Class I	8
7 Jun 2013	MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4	Device	Class I	2
16 May 2013	Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable	Device	Class II	7
11 Jan 2013	NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovascul	Device	Class II	24

All 11 events for Codman & Shurtleff Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Incorrect coil length on the label"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Japan"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 4 Jun 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.