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.
FDA Recall Z-0154-2014 · Posted 2013-11-05
Advertisement
Recalling FirmMedtronic Vascular, Inc.
Recall StatusTerminated
Product CodeNIQ
Date Initiated2013-10-07
Date Terminated2014-02-11
Product Quantity201 units
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.
Firm Action
Urgent Medical Device Recall Letters were sent on October 7, 2013 via UPS 3-day service.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement