CLASS II Device recall · Reported 29 Oct 2014 · FDA Enforcement Report

Codman Lumbar Drainage Catheter Kit II with EDS recalled

Codman & Shurtleff is recalling Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System), distributed nationwide in the US. The recall was initiated on 15 Sep 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots with expiration on or before August 2017 (2017-08)

Quantity recalled1145 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0091-2015
FDA event ID: 69262
Recalling firm: Codman & Shurtleff, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 15 Sep 2014
FDA classified: 20 Oct 2014
Reported: 29 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

15 Sep 2014	Recall initiated by company
20 Oct 2014	Classified by FDA	+35 days
29 Oct 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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)

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 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

Where it was distributed

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

Nationwide

Questions about this recall

Is Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) recalled?

Yes. Codman & Shurtleff recalled Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) on 15 Sep 2014. The recall is Class II and its status is Terminated. Recall number Z-0091-2015.

Why was it recalled?

Which lots are affected?

All lots with expiration on or before August 2017 (2017-08)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Codman & Shurtleff

All 59

Reported	Class	Recall	Company	Reason	Where
21 Aug 2019Device	CLASS II	Galaxy G3 Mini Microcoil Delivery System Product No: GLM915030 recalled	Codman & Shurtleff	Other	CA
3 Jun 2015Device	CLASS II	Codman 3000 Series Refill Set- Huber needles recalled	Codman & Shurtleff	Packaging Defects	Nationwide
29 Oct 2014Device	CLASS II	Codman EDS 3 Drainage System with Ventricular Catheter recalled	Codman & Shurtleff	Packaging Defects	Nationwide
29 Oct 2014Device	CLASS II	Codman EDS 3 Drainage System (no Ventricular Catheter) recalled	Codman & Shurtleff	Packaging Defects	Nationwide
20 Aug 2014Device	CLASS II	Codman Certas - In line Valve recalled by Codman & Shurtleff	Codman & Shurtleff	Packaging Defects	Nationwide

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