Stryker Target Nano Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may reduce stretch resistance, increasing the risk of coil stretching.
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. The hazard involves a structural defect (reduced stretch resistance) in a medical device that could lead to device malfunction (coil stretching), representing a risk of harm where injury has not yet been reported in the source text.
Plain-English summary
Stryker Neurovascular is recalling specific units of Target Nano coils due to a manufacturing defect. The company identified that some units do not have the intended stretch resistance. This issue stems from potential damage to the sutures inside the coil that provide this resistance.
The defect can lead to an increased occurrence of coil stretching. The affected product is the Target Helical Nano 2mm x 2cm, Model Number M0035452020. The recall covers 45,302 units worldwide, with 8,188 units distributed in the United States. Specific lot numbers and expiration dates are listed in the agency's structured data.
These devices are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The recall is classified as Class II by the FDA. Healthcare providers and patients should consult the manufacturer or the FDA for specific instructions on handling the affected devices.
The recalled product
- Product
- Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M0035452020 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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