Stryker GDC 360 Detachable Coils Recalled for Incorrect DFU Packaging
Stryker Neurovascular is recalling GDC 360 Detachable Coils because an incorrect Device Form Unique (DFU) was packaged with two lots.
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 the source text identifies the issue as a packaging/documentation error (incorrect DFU) without reporting any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Neurovascular is recalling GDC-10 360 SOFT 10MM X 20CM SR Detachable Coils (Model M0033471020SR0) due to a packaging error. The recall involves 316 total units across two models, specifically lots 17074659, 17581672, and 18617200.
The recall was initiated because an incorrect Device Form Unique (DFU) was packaged with the coils. These medical devices are intended for the embolization of intracranial aneurysms that are considered very high risk or inoperable by traditional techniques.
The affected products were distributed worldwide, including in the United States and various international markets. Healthcare providers and facilities should verify their inventory against the specific model and lot numbers listed and contact Stryker Neurovascular for further instructions.
The recalled product
- Product
- GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because of their morphology, their location, or the patients general medical…
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurology
- Hazard
- 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 (4)
- Model number: M0033471020SR0
- Lot codes: 17074659
- 17581672
- and 18617200.
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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