Agency classClass IIOur severity:High FDA (Devices)·Z-2169-2016·Announced 2016-07-20

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, and the defect involves a structural failure (reduced stretch resistance) in a medical device used for vascular occlusion, which presents a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Stryker Neurovascular is recalling specific units of Target Detachable Coils, including the Target Helical Nano 1.5 mm x 2 cm model. The recall affects 45,302 units worldwide, with 8,188 units distributed in the United States. The products were distributed to numerous countries, including the US, Canada, Australia, and various nations in Europe, Asia, and South America.

The recall was initiated because some units do not have the intended stretch resistance. Stryker Neurovascular identified that the sutures inside the coil, which are responsible for providing this resistance, may have been damaged during the manufacturing process. This defect can lead to an increased occurrence of coil stretching.

Healthcare providers and facilities that have received these products should stop using them and contact Stryker Neurovascular for instructions on how to return or dispose of the affected units. Patients who have had these coils implanted should consult their healthcare provider for guidance on monitoring or further action.

The recalled product

Product: Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M0035431520 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
Hazard: structural-defect
device-failure

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.

See all 28 products in this recall →

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