Drug recall
Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg…
FDA recall event 66532 · Class II · Medtronic Vascular, Inc.
Key facts
| Event ID | 66532 |
|---|---|
| Recall numbers | Z-0154-2014 |
| Recalling firm | Medtronic Vascular, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Oct 7, 2013 |
| Report date | Nov 13, 2013 |
| Termination date | Feb 11, 2014 |
| City | Santa Rosa |
| State | CA |
| Country | United States |
| FEI number | 3001452571 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: