Medtronic Strata II Shunt Assembly Kit, Small, Catalog No.… recallZ-0399-2014 · Medtronic Neurosurgery · initiated Nov 18, 2013
Class II Terminated All recalls posted in November 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neurosurgery or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Other
What the company is doing
Medtronic Neurosurgery sent an Urgent Medical Device Recall letter dated November 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to provide a copy of the letter to all those who need to be aware of the matter within their organization or to any organization where the potentially affected product may have been transferred. Customers with questions were instructed to call 805-571-8725.
Recall details
- Recall number
- Z-0399-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 18, 2013
- Posted by the FDA
- Nov 26, 2013
- Recalling firm
- Medtronic Neurosurgery
- Quantity
- 5 units
- Product code
- JXG
- FDA submissions
- K042465
- Distribution
- 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.
Product description
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.
Code information (models, lots, serial numbers)
Lot Numbers: D22311; D37565.
Other devices under the same FDA submission
5 devices cleared under K042465 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Delta® 25131-5Medtronic Ps Medical, Inc. · Shunt, central nervous system and components9 reports
- Delta® 25131-5Medtronic Ps Medical, Inc. · Shunt, central nervous system and components3 reports
- Strata® 27888Medtronic Ps Medical, Inc. · Shunt, central nervous system and components3 reports
- Delta® 25131-2Medtronic Ps Medical, Inc. · Shunt, central nervous system and components2 reports
- Strata® 27888Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 66882).
- Z-0397-2014 · TerminatedCSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Reg…
- Z-0398-2014 · TerminatedMedtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ve…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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