FDA Device recall Z-0264-2014
ProVia¿ CROSSING GUIDEWIRE
- FDA Device
- Class I
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class I recall of ProVia¿ CROSSING GUIDEWIRE by Medtronic Vascular, citing potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic guide wires are steerable guide wires that are used for the introduction and….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0264-2014 |
| 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
ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS 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. 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. Medt
Identifiers
| code_info | G13A00130 G13A01300 GT414 GU543 GV117 GV118 GV121 GV381 GV382 GV919 GW768 Additional Lots Identified: GV14…G13A00130 G13A01300 GT414 GU543 GV117 GV118 GV121 GV381 GV382 GV919 GW768 Additional Lots Identified: GV143 GV926 GV927 G13A00133 G13A00134 G13A01167 G13A01912 G13A00136 G13A00137 G13A01938 |
|---|
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-0264-2014%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.