FDA Device recall Z-0154-2014
Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm
- FDA Device
- Class II
- terminated
- Published 2013-11-13
On 2013-11-13 the FDA classified a Class II recall of Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm by Medtronic Vascular, citing 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 m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0154-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-07 |
| Published | 2013-11-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Vascular |
| Distribution | US |
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
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.
Identifiers
| code_info | Model: RSINT30034UX; Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0154-2014%22
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