Agency classClass IIOur severity:High FDA (Devices)·Z-2164-2016·Announced 2016-07-20

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, increasing the risk of 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 hazard involves a structural defect in a medical device used for vascular procedures. No injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Neurovascular is recalling specific units of Target Detachable Coils, including the TARGET 360 NANO 1.5 MM X 4 CM model. The recall affects 45,302 units worldwide, with 8,188 units distributed in the United States. The product is 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 determined that the sutures inside the coil, which provide this resistance, may have been damaged during manufacturing. This defect can lead to an increased occurrence of coil stretching.

The affected products were distributed worldwide, including in the United States and numerous other countries. The source text does not specify instructions for consumers or healthcare providers regarding the disposal or replacement of these devices.

The recalled product

Product: Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M0035421540 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

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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