Stryker Neurovascular Medical Devices 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 and involves a labeling error regarding shelf-life data without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Neurovascular is recalling specific medical devices, including the GDC-18 360 18MM X 30CM, Excelsior SL-10/Excelsior 1018 Microcatheter, GDC 10, 18 Coils, GDC 18-Fibered VortX Shape Coil, GDC 18-Fibered VoliX Shape Coil, 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 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 manufactured by Stryker Neurovascular in Cork, Ireland, and distributed by Stryker Neurovascular in Fremont, California.
Healthcare providers and facilities should check their inventory for the affected catalog numbers and stop using the recalled devices. Stryker Neurovascular is the recalling firm responsible for managing the recall.
The recalled product
- Product
- Stryker brand GDC-18 360 18MM X 30CM, Catalog Number: M00334818300; Product is manufactured by Stryker Neurovascular, Cork, Ireland and distributed by Stryker Neurovascular, Fremont, CA Excelsior SL-10/Excelsior 1018 Microcatheter: Stryker Neurovascular Microcatheters are…
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — 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)
- 17008718
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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