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 the internal sutures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 used for vascular procedures, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Stryker Neurovascular is recalling specific units of the Target Detachable Coils, specifically the TARGET 360 NANO 2MM X 4CM model (Model Number M0035442040). 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 Stryker Neurovascular became aware that 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.
The recall affects 45,302 units worldwide, including 8,188 units in the United States. The affected lots have expiration dates ranging from May 2018 to May 2019. The products were distributed nationwide in the US and in numerous international locations. Healthcare providers should stop using the affected units and contact Stryker Neurovascular for further instructions.
The recalled product
- Product
- Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040 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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