Stryker Target Detachable Coils Recalled for Manufacturing Defect
Stryker Neurovascular is recalling Target Detachable 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 in a medical device used for vascular occlusion, which presents a risk of harm (coil stretching) even though no injuries or illnesses are explicitly reported in the source text.
Plain-English summary
Stryker Neurovascular is recalling specific units of Target Detachable Coils, including the TARGET 360 NANO 2.5 MM X 4CM model. The recall involves 45,302 units worldwide, with 8,188 units distributed in the United States. The products were distributed globally, including in the US, Australia, Canada, and numerous European and Asian countries.
The recall was initiated because some units do not have the intended stretch resistance. Stryker Neurovascular identified 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.
These devices are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442540 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
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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