Recall Z-0263-2014— Medtronic Vascular
Class I · Terminated
Class I FDA medical device recall by Medtronic Vascular, initiated 2013-10-21, terminated 2014-12-15. It names one FDA 510(k) clearance: K970466. 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..
- 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
1 on FDA's recordK-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
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 for recall
Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
Data sourced from openFDA. This site is unofficial and independent of the FDA.