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.
- Company
- Medtronic Vascular, Inc.
- Recall Initiated
- October 7, 2013
- Posted
- November 5, 2013
- Terminated
- February 11, 2014
- Recall Number
- Z-0154-2014
- Quantity
- 201 units
- Firm Location
- Santa Rosa, CA
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Model: RSINT30034UX; Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.
Root Cause
Process control
Action Taken
Urgent Medical Device Recall Letters were sent on October 7, 2013 via UPS 3-day service.
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