Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1808-2013·Announced 2013-07-31

Stryker Neuroform 3 Stent System Recalled for Labeling Mismatch

Stryker Neurovascular is recalling 23 units of the Neuroform 3 Microdelivery Stent System because the model numbers on the outer carton and inner pouch labels do not match.

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 the source text identifies the issue as a labeling mismatch without reporting any illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving labeling errors or low-risk issues.

Plain-English summary

Stryker Neurovascular is recalling 23 units of the Stryker brand Neuroform 3 Microdelivery Stent System. The affected units are the 4.5 mm x 20 mm size, with REF Catalog Number E345020 and Model/Product Number M003450200. The product is manufactured by Boston Scientific Corporation and distributed by Stryker Neurovascular. The recall involves units with Lot 15391019 and an expiration date of 2015-07.

The recall was initiated because the device is labeled incorrectly. The Model Number on the outer carton states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent), while the inner pouch label states UPN M003E3450300 (4.5mm x 30 mm Neuroform 3 Stent). Although both labels reference the same lot number, the mismatch in model numbers creates a labeling discrepancy.

The affected units were distributed internationally, including to Austria, China, and Germany. The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms. No specific consumer actions are detailed in the source text beyond the identification of the recall.

The recalled product

Product: Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA The Neuroform…
Manufacturer: Stryker Neurovascular
Category: Medical Device — Neurovascular Stent
Hazard: mis-labeling
Affected units: 23

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 (3)

Code: M003450200
Lot 15391019
Expiration Date: 2015-07

Distribution

Distribution scope not specified by the agency.

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