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Medtronic Vascular Recall: THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide

Medtronic Vascular Recall: THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medtronic Vascular; Product: THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the

Recalling firmMedtronic Vascular
ProductTHUNDER¿ Steerable Guidewire; Model: LVTNDR190S 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 recallPotential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
ClassificationClass I (most serious — reasonable probability of serious health consequences or death)
StatusTerminated
DistributionWorldwide distribution: US (Nationwide) including states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV; and countries of: Albania, Algeria, Argentina, Australi
Recall initiated20131021
Recall numberZ-0267-2014
Categorydevice
StateMA
CountryUnited States

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