Medtronic Archer Super Stiff Guidewire 0 — Class II medical device recall Z-1017-2013
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2013-04-03, distributed in FL, MN, OH. Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire,
| Recall number | Z-1017-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, United States |
| Recall initiated | 2013-03-13 |
| Classified | 2013-03-28 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2013-11-21 |
| Distributed | FL, MN, OH |
| Countries outside the US | BE, DE, FR, GB, NL, TR |
| Quantity | 225 units |
| Lot numbers | GFWA0387 |
| Model numbers | ARCSJ200W |
Product
Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.
Reason for recall
Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use.
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-1017-2013. 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.