CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report

Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID recalled

Medtronic Vascular is recalling Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID; Stent length, distributed nationwide in the US. The recall was initiated on 7 Oct 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: RSINT30034UX; Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.

Quantity recalled201 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0154-2014
FDA event ID: 66532
Recalling firm: Medtronic Vascular, Santa Rosa, CA
Classification: Class II
Status: Terminated
Recall initiated: 7 Oct 2013
FDA classified: 5 Nov 2013
Reported: 13 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

7 Oct 2013	Recall initiated by company
5 Nov 2013	Classified by FDA	+29 days
13 Nov 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model: RSINT30034UX; Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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