FDA Device recall Z-0266-2014
COUGAR¿ Steerable Guidewire
- FDA Device
- Class I
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class I recall of COUGAR¿ Steerable Guidewire by Medtronic Vascular, citing potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0266-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-10-21 |
| Published | 2013-11-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Vascular |
| Distribution | US |
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 a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another
Reason
Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
Identifiers
| code_info | G13A00805 G13A00814 G13A00815 G13A01447 G13A01450 GW547 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0266-2014%22
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