Medtronic Vascular, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0154-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: October 7, 2013

Date Posted: November 13, 2013

Recall Number: Z-0154-2014

Event ID: 66532

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.

Status: Terminated

Product Quantity: 201 units

Code Information:

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

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated