FDA Device recall Z-0263-2014
THUNDER¿ Extra Support Guidewire
- FDA Device
- Class I
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class I recall of THUNDER¿ Extra Support 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-0263-2014 |
| 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
THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S 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 | G13A00117 G13A00735 G13A00792 G13A00794 G13A01324 GV259 GV261 GV276 GV287 GV847 GV848 GV849 GV851 GV852 GW690 GW758 GU141 GU959 |
|---|
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-0263-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.