Stryker Neurovascular Microcatheters Recalled for Shelf-Labeling Errors
Stryker Neurovascular is recalling specific microcatheters and coils because they were shipped with 'use by' dates that exceed 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 source text describes a labeling error regarding shelf-life dates without reporting any illnesses, injuries, or adverse health consequences, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Stryker Neurovascular is recalling specific medical devices, including the COMPLIANT 5MM X 30MM microcatheter, 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. These products are intended for use in the peripheral, coronary, and neurovasculature for diagnostic and therapeutic procedures.
The recall was initiated because the products were shipped with 'use by' dates that exceed currently available shelf-life data. The source text notes that all products remain within the earliest expiration date of April 2015.
The affected products were distributed nationwide in the United States and internationally to numerous countries, including Austria, Belgium, Germany, France, Great Britain, Italy, Canada, Australia, and Japan. Healthcare providers and facilities should check their inventory for the affected catalog numbers and stop using these products if they match the recalled description.
The recalled product
- Product
- Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; 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 inten
- 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)
- 17011548
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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