Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0397-2014·Announced 2013-12-04

Medtronic Recalls CSF-Unitized Shunts Due to Label Discrepancies

Medtronic Neurosurgery is recalling CSF-Unitized Shunts, Delta Shunt Assembly Kits, and Strata II Shunt Assembly Kits due to label discrepancies.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves label discrepancies, which aligns with the rubric for minor labeling errors or low-risk issues.

Plain-English summary

Medtronic Neurosurgery is recalling CSF-Unitized Shunts, Delta Shunt Assembly Kits, and Strata II Shunt Assembly Kits. The recall was initiated because these medical devices were found to have label discrepancies.

The affected products include CSF-Unitized Shunts in Low, Medium, and High Pressure configurations, as well as the Delta and Strata II Shunt Assembly Kits. These devices 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.

The recall involves 288 units total, with 147 units distributed in the United States. The products were distributed nationwide in the US and internationally to Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, the United Arab Emirates, and the United Kingdom. Specific lot numbers for the affected catalog items are listed in the official recall documentation.

The recalled product

Product: CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated…
Manufacturer: Medtronic Neurosurgery
Category: Medical Device — Neurosurgical Shunts
Hazard: mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

Lot Numbers: Catalog No. 46022: D27162
D30984
D3461 0
D35834
D37761
D39054
D39539. Catalog No. 46024: D13944
D14093
D14217
D14216
D33526
D39540. Catalog No. 46026: D35572
D39583.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Medtronic Neurosurgery under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Medtronic Neurosurgery

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Same hazard · mis labeling