Stryker GDC 360 Detachable Coils Recalled for Incorrect Device Formulation
Stryker Neurovascular is recalling 316 GDC 360 Detachable Coils because an incorrect Device Formulation Unit (DFU) was packaged with the product.
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 source text does not report any illnesses, injuries, or hospitalizations. The hazard is a packaging error (incorrect DFU) without explicit evidence of significant harm, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Neurovascular is recalling 316 units of GDC-18 360 11MM X 30CM Detachable Coils (Model M0033471020SR0). The recall involves lot numbers 17723781, 17735100, and 17818842. These sterile neurology devices are intended for the embolization of intracranial aneurysms that are considered very high risk or inoperable by traditional techniques.
The recall was initiated because an incorrect Device Formulation Unit (DFU) was packaged with two lots of the GDC 360 degree Detachable Coils. The FDA has classified this as a Class II recall.
The affected devices were distributed worldwide, including nationwide in the United States and in numerous international locations such as Canada, Mexico, and various countries in Europe, Asia, and South America. Healthcare providers and facilities should stop using the affected lots and contact Stryker Neurovascular for instructions on return or replacement.
The recalled product
- Product
- GDC-18 360 11MM X 30CM Detachable Coil Sterile; Model number: M0033471020SR0 Neurology: GDC 360 degree Detachable Coils are intended for embolization of those intracranial aneurysms that¿a because of their morphology, their location, or the patients general medical…
- Manufacturer
- Stryker Neurovascular
- Affected units
- 316
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 (3)
- Model Number: GDC-18 360 11MM X 30CM
- Lot numbers: 17723781
- 17735100 and 17818842.
Distribution
Part of a larger recall action
This product is one of 2 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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