Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing damage may have reduced the stretch resistance of internal sutures, potentially causing the coils to stretch.
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 in a medical device that could lead to device failure (coil stretching) without reporting specific injuries or hospitalizations, fitting the 'High' 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 Helical Nano 1 mm x 2 cm model. 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 the manufacturing process. This defect can lead to an increased occurrence of coil stretching.
The recall affects 45,302 units worldwide, with 8,188 units distributed in the United States. The products were distributed nationwide in the US and in numerous other countries, including Australia, Canada, and various nations in Europe, Asia, and South America. Healthcare providers and patients should contact Stryker Neurovascular for further instructions on how to proceed with the affected devices.
The recalled product
- Product
- Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035431020 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: M0035431020
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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