Stryker Neurovascular Microcatheters Recalled for Shelf-Life Labeling Errors
Stryker Neurovascular is recalling specific 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, but the specific issue is a labeling error regarding shelf-life dates where the products remain within the earliest expiration date, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Stryker Neurovascular is recalling specific lots of EXCELSIOR SL-10 PRE-SHAPED C 15OCM microcatheters, Excelsior SL-10/Excelsior 1018 Microcatheters, GDC 10, 18 Coils, GDC 18-Fibered VortX Shape 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 nationwide in the United States and internationally to Austria, Belgium, Czech Republic, Germany, France, Great Britain, Hungary, Italy, Lithuania, Netherlands, Norway, Poland, Slovakia, Spain, Turkey, Australia, Canada, Chile, Hong Kong, India, Korea, Malaysia, Russia, and Japan. The products are intended to assist in the delivery of diagnostic and therapeutic agents into the peripheral, coronary, and neurovasculature.
Healthcare providers and facilities should check their inventory for the specific catalog numbers and expiration dates mentioned in the recall notice. If the products are found, they should be removed from use and returned to Stryker Neurovascular or the distributor as directed by the company.
The recalled product
- Product
- Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular…
- 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 (1)
- 17048725
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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