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.
What this means for you
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, but the hazard is a labeling error regarding shelf-life dates rather than a structural defect or contamination, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Stryker Neurovascular is recalling specific lots of Excelsior SL-10/Excelsior 1018 Microcatheters, GDC 10, 18 Coils, GDC 18-Fibered VortX Shape Coils, and TransForm Occlusion Balloon Catheters. The recall was initiated because the products were 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 nationwide in the United States and internationally to countries such as Austria, Belgium, Germany, France, Great Britain, Italy, Canada, Australia, and Japan. The specific lot codes involved in this recall are 17046094, 17046139, 17046184, 17046229, and 17046274.
Healthcare providers and facilities should check their inventory for these specific catalog numbers and lot codes. If the products are found, they should be removed from use and returned to Stryker Neurovascular according to the instructions provided by the company.
The recalled product
- Product
- Stryker brand EXCELSIOR SL-10 PRE-SHAPED J 15OCM, Catalog Number: M0031681920; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheter
- 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 (5)
- 17046094
- 17046139
- 17046184
- 17046229
- 17046274
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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