Class 2 Device Recall Resolute Integrity Zotarolimuseluting Coronary Stent

• Date Initiated by Firm: October 07, 2013
• Date Posted: November 05, 2013
• Recall Status: Terminated on February 11, 2014
• Recall Number: Z-0154-2014
• Recall Event ID: 66532
• PMA Number: P110013S005
• Product Classification: Coronary drug-eluting stent - Product Code NIQ
• 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.
• Code Information: Model: RSINT30034UX; Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.
• Recalling Firm/ Manufacturer: Medtronic Vascular, Inc.; 3576 Unocal Pl; Santa Rosa CA 95403-1774
• For Additional Information Contact: Carlos Alfonso; 707-566-1110
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: Urgent Medical Device Recall Letters were sent on October 7, 2013 via UPS 3-day service.
• Quantity in Commerce: 201 units
• Distribution: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NIQ