Stryker Target Detachable Coils Recalled for Manufacturing Defect
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, and the hazard involves a structural defect in a medical device that could lead to device malfunction (coil stretching) without reported injuries or fatalities, 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 360 NANO 3MM X 4CM 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 defect can lead to an increased occurrence of coil stretching.
The affected products were distributed worldwide, including in the United States, Australia, Canada, and numerous other countries. Specific lot numbers and expiration dates are listed in the agency's recall record. Healthcare providers and patients should consult the recall notice for specific lot details and instructions on how to proceed.
The recalled product
- Product
- Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040 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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