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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 Recall
Resolute Integrity Zotarolimuseluting Coronary Stent
see related information
Date Posted November 05, 2013
Recall Status1 Terminated on February 11, 2014
Recall Number Z-0154-2014
Recall Event ID 66532
Premarket Approval
PMA Number
P110013
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, California 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 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NIQ and Applicant = MEDTRONIC INC.
PMAs with Product Code = NIQ and Applicant = MEDTRONIC IRELAND
PMAs with Product Code = NIQ and Applicant = MEDTRONIC VASCULAR
PMAs with Product Code = NIQ and Applicant = MEDTRONIC, INC.
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