Stryker Neurovascular Microcatheters Recalled for Incorrect Use-By Dates
Stryker Neurovascular is recalling certain microcatheters and coils because they were shipped with use-by dates exceeding available shelf-life data.
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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The specific issue is a labeling error regarding shelf-life data, which fits the criteria for a moderate severity recall involving minor labeling errors or precautionary measures.
Plain-English summary
Stryker Neurovascular is recalling specific lots of EXCELSIOR SL-10 microcatheters, GDC coils, and TransForm occlusion balloon catheters. The recall is due to products being shipped with "use by" dates that exceed currently available shelf-life data. All affected products remain within the earliest expiration date of April 2015.
The affected products were distributed worldwide, including in the United States and internationally to countries such as Austria, Belgium, Germany, France, Great Britain, and Japan. The specific lot codes involved in this recall are 17026534, 17026579, 17026624, 17026669, 17026714, 17026759, and 17026804.
Healthcare providers and facilities should check their inventory for these specific lot codes and stop using the affected devices. Stryker Neurovascular is the recalling firm for this action.
The recalled product
- Product
- Stryker brand EXCELSIOR SL-10 150CM 2 TIP, Catalog Number: M0031681890, Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters…
- Manufacturer
- Stryker Neurovascular
- Hazard
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 (7)
- 17026534
- 17026579
- 17026624
- 17026669
- 17026714
- 17026759
- 17026804
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Stryker Neurovascular 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.
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