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/ 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 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
|