ATTAIN HYBRID¿ Guide Wire — Class I medical device recall Z-0265-2014
Terminated recall by Medtronic Vascular, reported 2013-11-27, distributed nationwide. Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
| Recall number | Z-0265-2014 |
|---|---|
| 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 |
| Quantity | 1,674 |
| Reason classes | device malfunction |
| Model numbers | GWR419478, GWR419488, GWR419688 |
Product
ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
Reason for recall
Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0265-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.