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, 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. The hazard involves a structural defect in a medical device intended for vascular occlusion, which poses a risk of harm (increased coil stretching) even though specific injuries or illnesses are not explicitly reported in the source text.
Plain-English summary
Stryker Neurovascular is recalling specific units of Target Detachable Coils, specifically the Target Helical Nano 3mm x 6cm model (Model Number M0035453060). The recall involves 45,302 units worldwide, with 8,188 units distributed in the United States. The affected lots are 18499486, 18603584, and 19086497.
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.
These devices are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The recall covers distribution in the United States and numerous international locations including Australia, Canada, and various countries in Europe, Asia, and South America. Healthcare providers and patients should contact Stryker Neurovascular for further instructions regarding the affected devices.
The recalled product
- Product
- Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M0035453060 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:M0035453060
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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