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, potentially leading to increased 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, and the source describes a functional defect (reduced stretch resistance) in a medical device without reporting specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Neurovascular is recalling specific units of Target Detachable Coils, including the TARGET 360 NANO 1 MM X 2 CM model (Model Number M0035421020). These medical devices are 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. The sutures inside the coil that provide this resistance may have been damaged during manufacturing. This defect can lead to an increased occurrence of coil stretching.
A total of 45,302 units were distributed worldwide, with 8,188 units distributed in the United States. The affected products were distributed to numerous countries, including the US, Canada, Australia, and various nations in Europe, Asia, and South America. Healthcare providers and patients should consult the FDA recall notice for specific lot numbers and expiration dates to identify affected units.
The recalled product
- Product
- Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421020 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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