Z-0090-2015Class II

Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731...

Name: Z-0090-2015 Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731...
Creator: Codman & Shurtleff, Inc.
Published: 2014-09-15
License: https://open.fda.gov/license/

Cerenovus, Inc. / initiated 2014-09-15 / Terminated / root cause: design

FDA source

Codman & Shurtleff, Inc. began a recall of Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and... on 2014-09-15. FDA classified it as Class II and gives the reason as "tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0090-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-15
Posted: 2014-10-20
Terminated: 2017-08-11
Recalling firm: Cerenovus, Inc.
Product: Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)
Root cause tag: design
FDA root cause: Device Design
Action: Codman Neuro sent an Urgent Notice dated September 12, 2014, to all affected customers via overnight mailing and OUS customers notified via email the week of September 15, 2014. Accounts were requested to isolate all inventory of the affected product and return to Stericycle at the following address: Stericycle 2670 Executive Drive, Suite A Attn: Event #8894 Indianapolis, IN 46241 For patients currently being managed with the EDS 3 System, the system should be replaced immediately. In the case where no substitute drainage system is immediately available, the EDS 3 System may continue to be used until an alternative product can be obtained. If you have any questions or concerns regarding this notification, please contact your local Codman Neuro Representative or Scientific and Medical Affairs at [email protected] or (866) 685-7325. For questions regarding this recall call 508-880-8000.
Quantity in commerce: 93,558 units
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to: United Arab Emirates Argentina Austria Australia Aruba Belgium Bahrain Bolivia Brazil Bahamas Canada Switzerland Chile People's Republic of China Columbia Costa Rica Cyprus Czech Republic Germany Algeria Estonia Egypt Spain Finland France Gabon Great Britain French Guiana Greece Guatemala Hong Kong Croatia Hungary Ireland Israel India Iran Italy Jordan Kenya Kuwait Kazakhstan Lebanon Lithuania Luxembourg Latvia Mauritius Mexico Malaysia Mozambique New Caledonia Nigeria Netherlands Norway New Zealand Oman Panama Peru Poland Palestine Portugal Reunion Romania Serbia Russian Federation Rwanda Saudi Arabia Sweden Singapore Slovenia Slovakia Tunisia Turkey Trinadad And Tobago Taiwan Ukraine Uruguay Venezuela Mayotte South Africa
Product codes and lots: All lots with expiration on or before August 2017 (2017-08)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0090-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0089-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-20
Z-0090-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-20
Z-0091-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-20

Product code JXG

K061568Class IICodman Eds 3 Csf External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738Codman & Shurtleff, Inc. / cleared 2006-09-29

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)