Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage to internal sutures 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 functional defect (reduced stretch resistance) in a medical device used for vascular occlusion, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Stryker Neurovascular is recalling specific units of Target Detachable Coils, including the TARGET 360 NANO 1.5 MM X 3 CM model. The recall affects 45,302 units worldwide, with 8,188 units distributed in the United States. The product is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
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 damage can lead to an increased occurrence of coil stretching.
The affected products were distributed worldwide, including in the United States, Australia, Canada, and numerous countries in Europe, Asia, and South America. Healthcare providers and patients should check their inventory and patient records for the specific lot numbers and expiration dates listed in the official recall notice. If you have used or are considering using these devices, contact Stryker Neurovascular or your healthcare provider for guidance on next steps.
The recalled product
- Product
- Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M0035421530 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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