Stryker GDC 360 Coils Recalled for Expiration Date Violations
Stryker Neurovascular is recalling GDC 360 coils, Target coils, and Gateway PTA Balloon Catheters shipped beyond their expiration dates.
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 documentation/shipping error (expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Neurovascular is recalling specific units of GDC 360 coils, Target coils, and Gateway PTA Balloon Catheters. The recall was initiated because these medical devices were shipped to US customers beyond their expiration dates.
The affected products include the GDC-18 360 20mm x 33cm model (Model M00334820330, Lot 12881100, Exp. Jul 2012). The distribution pattern indicates shipments to customers in Virginia, New Hampshire, Ohio, and Texas.
Healthcare facilities and customers who received these specific lots should stop using the devices and contact Stryker Neurovascular for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- GDC-18 360 20mm x 33cm ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a)…
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
- Hazard
- Affected units
- 1
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 M00334820330
- Lot number: 12881100
- Exp. Jul 2012.
Distribution
Part of a larger recall action
This product is one of 5 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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