[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
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | 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 coronary and peripheral vasculature, and may be used to reach and cross |
|---|---|
| Brand / manufacturer | Medtronic Vascular |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0266-2014 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 21 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.