CLASS II Device recall · Reported 4 Dec 2013 · FDA Enforcement Report

Medtronic Strata II Shunt Assembly Kit, Small recalled

Medtronic Neurosurgery is recalling Medtronic Strata II Shunt Assembly Kit, Small, distributed nationwide in the US. The recall was initiated on 18 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: D22311; D37565.

Quantity recalled5 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-0399-2014
FDA event ID: 66882
Recalling firm: Medtronic Neurosurgery, Goleta, CA
Classification: Class II
Status: Terminated
Recall initiated: 18 Nov 2013
FDA classified: 26 Nov 2013
Reported: 4 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

18 Nov 2013	Recall initiated by company
26 Nov 2013	Classified by FDA	+8 days
4 Dec 2013	Published in enforcement report	+8 days

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

Reason for recall

Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

Product as listed by the FDA

Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity.

Where it was distributed

Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.

Nationwide

Questions about this recall

Why was it recalled?

Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

Which lots are affected?

Lot Numbers: D22311; D37565.

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

Other products in this recall event

2 other products · FDA event 66882

This product is part of a recall event; the main page for the event is Medtronic Delta Shunt Assembly Kit with Bioglide Small recalled.

Reported	Class	Recall	Company	Reason	Where
4 Dec 2013	CLASS II	Medtronic Delta Shunt Assembly Kit with Bioglide Small recalled	Medtronic Neurosurgery	Other	Nationwide
4 Dec 2013	CLASS II	CSF-Unitized Shunt, Contoured Regular, Low Pressure recalled	Medtronic Neurosurgery	Other	Nationwide

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