Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures may cause the coils to stretch.
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 hazard involves a structural defect in a medical device used for vascular occlusion where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Stryker Neurovascular is recalling specific units of Target Detachable Coils, specifically the TARGET 360 NANO 3MM X 6CM model (Model Number M0035443060). These medical devices are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
The recall is due to a manufacturing defect where the sutures inside the coil, which provide stretch resistance, may have been damaged. This damage can lead to an increased occurrence of coil stretching, meaning the device may not have the intended stretch resistance.
The recall affects 45,302 units worldwide, with 8,188 units distributed in the United States. The products were distributed nationwide in the US and in numerous other countries including Australia, Canada, and various nations in Europe, Asia, and South America. Healthcare providers and patients should contact Stryker Neurovascular for instructions on how to proceed with the affected devices.
The recalled product
- Product
- Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
- Manufacturer
- Stryker Neurovascular
- Category
- Medical Device — Neurovascular
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 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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