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[Recalled] Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular a

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductTarget Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421030 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Brand / manufacturerStryker Neurovascular
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2161-2016
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date06 June 2016
EAN / barcode18604566

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Stryker Neurovascular

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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