FDA Device recall Z-0268-2014
ZINGER¿ Steerable Guidewire
- FDA Device
- Class I
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class I recall of ZINGER¿ 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-0268-2014 |
| 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
ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S 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 | G13A00118 G13A00715 G13A00716 G13A00843 G13A00937 G13A01601 G13A01620 G13A01621 G13A01638 G13A01639 G13A01650 GV854 GW761 |
|---|
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-0268-2014%22
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