FDA Medical Device Recalls (openFDA)
Medtronic Vascular, Inc.: 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.
- Recall number
- Z-0154-2014
- Recalling firm
- Medtronic Vascular, 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.
- Status
- Terminated
- Initiated
- 2013-10-07
- Posted
- 2013-11-05
- Terminated
- 2014-02-11
- Reason
- 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
- Process control
- Action
- Urgent Medical Device Recall Letters were sent on October 7, 2013 via UPS 3-day service.
- Quantity
- 201 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Model: RSINT30034UX; Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014.
- 510(k) numbers
- not on file
- PMA numbers
- ["P110013S005"]
- Product code
- NIQ
- Firm FEI
- 3001452571
- Firm city
- Santa Rosa
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28