Reported Nov 13, 2013 · Terminated
Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in…
Medtronic Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Vascular, Inc. · 3576 Unocal Pl · Santa Rosa, CA · 95403-1774
Is this the product you have?
- Resolute Integrity
- Zotarolimus-eluting Coronary StentStent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland
- Distributed byMedtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients
- Lot codes and dates
- ModelRSINT30034UX
- Customer Facing NumberRSIST30034UX
- Expiration date25 May 2014
- Amount recalled
- 201 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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