Stryker Wingspan Stent System Recalled for Coating Damage
Stryker Neurovascular is recalling Wingspan Stent Systems because use-related coating damage was reported on the delivery catheter shafts.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a physical defect (coating damage) in a high-risk medical device without reporting specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Neurovascular is recalling the Wingspan Stent System, a prescription-only medical device sterilized with ethylene oxide. The recall involves 11,585 units distributed in China across all lots.
The recall was initiated because use-related coating damage was reported on the delivery catheter shafts of the Wingspan delivery catheters. This defect could potentially affect the performance of the device during use.
Healthcare providers and patients who have used or are using these specific catalog numbers should contact Stryker Neurovascular for further instructions on how to proceed.
The recalled product
- Product
- Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200…
- Manufacturer
- Stryker Neurovascular
- Affected units
- 11,585
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)
- All lots.
Distribution
Distribution scope not specified by the agency.
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