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U.S. Department of Health and Human Services

Class 2 Device Recall Resolute Integrity Zotarolimuseluting Coronary Stent

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  Class 2 Device Recall Resolute Integrity Zotarolimuseluting Coronary Stent see related information
Date Initiated by Firm October 07, 2013
Date Posted November 05, 2013
Recall Status1 Terminated 3 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/
Medtronic Vascular, Inc.
3576 Unocal Pl
Santa Rosa CA 95403-1774
For Additional Information Contact Carlos Alfonso
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 2
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 and Original Applicant = Medtronic Vascular