Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3 — Class II medical device recall Z-0154-2014
Terminated recall by Medtronic Vascular, Inc., reported 2013-11-13, distributed nationwide. A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten S
| Recall number | Z-0154-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Inc., Santa Rosa, CA, United States |
| Recall initiated | 2013-10-07 |
| Classified | 2013-11-05 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 201 units |
| Model numbers | RSINT30034UX |
| Expiration dates | 2014-05-25 |
Product
Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients.
Reason for recall
A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart incorrectly referencing a 2.25 mm diameter instead of the correct 3.0mm.
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-0154-2014. 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.