Reported Dec 4, 2013 · Terminated
CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium…
Medtronic Neurosurgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neurosurgery · 125 Cremona Dr · Goleta, CA · 93117-3083
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
46022 | CSF-Unitized Shunt, Contoured Regular, Low Pressure |
46024 | CSF-Unitized Shunt, Contoured Regular, Medium Pressure |
46026. | CSF-Unitized Shunt, Contoured Regular, High Pressure, CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity. |
- Lot codes and dates
- Lot Numbers
Catalog No. 46022: D27162D30984D3461 0D35834D37761D39054D39539. Catalog No. 46024: D13944D14093D14217D14216D33526D39540. Catalog No. 46026: D35572D39583
- Lot Numbers
- Amount recalled
- 288 units total (147 units in US)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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