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 involves a medical device with a structural defect that could lead to device failure (coil stretching) in a high-risk clinical setting, but the source text does not report any injuries, illnesses, or deaths.
Plain-English summary
Stryker Neurovascular is recalling specific units of Target Nano detachable coils. The recall is due to a manufacturing defect where the sutures inside the coil, which provide stretch resistance, may have been damaged. This defect can lead to an increased occurrence of coil stretching.
The affected product is the Target Helical Nano 2mm x 3cm, Model Number M0035452030. These neurology devices are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The recall covers 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 other countries including Australia, Canada, and the United Kingdom.
Healthcare providers and patients should contact Stryker Neurovascular for further instructions regarding the affected devices. The specific lot numbers and expiration dates for the recalled units are listed in the official recall documentation.
The recalled product
- Product
- Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M0035452030 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
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- MODEL Number::M0035452030
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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