Stryker Target Detachable Coils Recalled for Reduced Stretch Resistance
Stryker Neurovascular is recalling Target Detachable Coils because manufacturing defects may have damaged internal sutures, leading to increased coil stretching.
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, and the source text describes a functional defect (reduced stretch resistance) in a medical device without reporting specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Neurovascular is recalling specific units of the Target Detachable Coils, specifically the TARGET 360 NANO 1.5 MM X 2 CM model (Model Number M0035421520). 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. Stryker Neurovascular has determined that the sutures inside the coil, which provide this stretch resistance, may have been damaged during the manufacturing process. This damage 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 U.S. and in numerous other countries, including Australia, Canada, and various nations in Europe, Asia, and South America. The affected lots have expiration dates ranging from May 2018 to May 2019. Healthcare providers and patients should contact Stryker Neurovascular for further instructions on how to proceed with the recall.
The recalled product
- Product
- Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 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
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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