Agency classClass IIOur severity:High FDA (Devices)·Z-2167-2016·Announced 2016-07-20

Stryker Target Nano Coils Recalled for Reduced Stretch Resistance

Stryker Neurovascular is recalling Target Nano coils because manufacturing damage may have reduced their stretch resistance, potentially 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. The hazard involves a structural defect in a medical device intended for neurovascular use, which poses a risk of harm (increased coil stretching) even though no specific injuries are reported in the source text.

Plain-English summary

Stryker Neurovascular is recalling specific units of Target Detachable Coils, specifically the Target Helical Nano 1 mm x 3 cm model (M0035431030). The recall affects 45,302 units worldwide, with 8,188 units distributed in the United States. The products were distributed globally, including in the US, Australia, Canada, and numerous European and Asian countries.

The recall was initiated because Stryker Neurovascular determined that some units do not have the intended stretch resistance. The company 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 source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the defect. Healthcare providers and patients should consult the FDA or the manufacturer for specific instructions on how to manage the affected devices.

The recalled product

Product: Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035431030 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-malfunction

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: M0035431030

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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