Recall Z-0264-2014— Medtronic Vascular

Name: FDA recall Z-0264-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-21

Class I · Terminated

Class I FDA medical device recall by Medtronic Vascular, initiated 2013-10-21, terminated 2014-12-15. It names 2 FDA 510(k) clearances: K100470, K091582. 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.

Recalling firm: Medtronic Vascular
Classification: Class I
Status: Terminated
Initiated: 2013-10-21
Terminated: 2014-12-15
Firm location: Danvers, MA, United States

510(k) clearances named in this recall

2 on FDA's record

K100470 — GTX 12 GIDEWIREMedtronic, Inc.·cleared 2010-04-21
K091582 — GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15Medtronic Vascular·cleared 2009-12-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.