Medtronic Archer 0 — Class II medical device recall Z-1019-2013
Terminated recall by Medtronic Inc. Cardiac Rhythm Disease Management, reported 2013-04-03, distributed nationwide. Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) S
| Recall number | Z-1019-2013 |
|---|---|
| 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 | 2014-02-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BO, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FI, FR, GB, GR, HK, HR, HU, ID, IL, IN, IR, IS, IT, JO, KR, KW, LB, LV, MA, MY, NL, NO, NZ, OM, PH, PL, PT, RS, SA, SE, SG, SK, SV, TH, TR, TW, VE, VN, ZA |
| Quantity | 27,682 devices |
| Lot numbers | GFWC1124, GFWC1501, GFWC1502, GFWC1503, GFWC1506, GFWC1507, GFWC1508, GFWC2138, GFWC2652, GFWC2653, GFWD0353, GFWD0881, GFWD0882, GFWD0883, GFWD0884, GFWD0885, GFWD2048, GFWD2049, GFWD2050, GFWD2051, GFWD2052, GFWD3256, GFWE0743, GFWE0744, GFWE0745, GFWE0746, GFWE0747, GFWE0750, GFWE0751, GFWE0752, GFWE0753, GFWE3710, GFWE3711, GFWE4272, GFWE4273, GFWE4274, GFWE4275, GFWF0142, GFWF0143, GFWF0144 and 74 more |
| Model numbers | ARCDJ260W, ARCSJ200W, ARCSJ260W |
Product
Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.
Reason for recall
Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil 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-1019-2013. 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.