ProVia¿ CROSSING GUIDEWIRE — Class I medical device recall Z-0264-2014
Terminated recall by Medtronic Vascular, reported 2013-11-27, distributed nationwide. Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic guide w
| Recall number | Z-0264-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Danvers, MA, United States |
| Recall initiated | 2013-10-21 |
| Classified | 2013-11-15 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2014-12-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EG, ES, FI, FR, GB, GR, GY, HK, HN, HR, HU, IE, IL, IN, IS, IT, JO, JP, KW, LB, LU, MX, MY, NI, NL, NO, NP, NZ, OM, PL, PT, QA, RS, SA, SE, SG, SK, TH, TN, TW, UY, ZA |
| Reason classes | device malfunction |
| Model numbers | 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS |
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 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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.