Resolute Integrity Zotarolimus-eluting Coronary Stent recall
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.
Why was Resolute Integrity Zotarolimus-eluting Coronary Stent 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model: RSINT30034UX; Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.
- 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.
- Recalling firm
- Medtronic Vascular, Inc.
- Quantity
- 201 units
- Distribution
- Nationwide Distribution.
- Recall date
- November 13, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)