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[Recalled] COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the c

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductCOUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross
Brand / manufacturerMedtronic Vascular
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0266-2014
Country of noticeUnited States
Risk levelClass I
Hazard typerecall
Notice date21 October 2013

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

This Class I 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

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

Read the full official notice →

Related recalls from Medtronic Vascular

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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