Recall Z-0154-2014 ยท NIQ Coronary Drug-Eluting Stent
Medtronic Vascular, Inc.
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.
| Date | Nov 5, 2013 (initiated Oct 7, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | Urgent Medical Device Recall Letters were sent on October 7, 2013 via UPS 3-day service. |
| Quantity | 201 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.