Z-0154-2014Class II

Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg...

Name: Z-0154-2014 Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg...
Creator: Medtronic Vascular, Inc.
Published: 2013-10-07
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-10-07 / Terminated / root cause: manufacturing process

FDA source

Medtronic Vascular, Inc. began a recall of Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland... on 2013-10-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0154-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-07
Posted: 2013-11-05
Terminated: 2014-02-11
Recalling firm: Medtronic, Inc.
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.
Product code: NIQ Coronary Drug-Eluting Stent
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Model: RSINT30034UX; Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0154-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0154-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-05

Product code NIQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)