Recall Z-0154-2014— Medtronic Vascular, Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Vascular, Inc., initiated 2013-10-07, terminated 2014-02-11. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Medtronic Vascular, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-07
- Terminated
- 2014-02-11
- Firm location
- Santa Rosa, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.