Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may reduce stretch resistance, potentially causing the coils to stretch.
What this means for you
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. Per the rubric, a Class II recall without explicit reports of hospitalization or death falls into the 'High' category (Score 3), representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stryker Neurovascular is recalling specific units of Target Detachable Coils, specifically the Target Helical Nano 1.5 mm x 4 cm model (Model Number M0035431540). The recall affects 45,302 units worldwide, with 8,188 units distributed in the United States. The products were distributed nationwide in the U.S. and in numerous countries worldwide.
The recall was initiated because Stryker Neurovascular identified that some units do not have the intended stretch resistance. The company determined that the sutures inside the coil, which provide this resistance, may have been damaged during the manufacturing process. This defect can lead to an increased occurrence of coil stretching.
The source text does not specify reported injuries or illnesses associated with this defect. Consumers and healthcare providers should refer to the official FDA recall notice for specific instructions on how to handle the affected devices.
The recalled product
- Product
- Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M0035431540 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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