Medtronic Vascular Galway Limited: Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery System, UPN 00613994400505, model #IDERES25024X. Manufacturer: Medtronic, Inc. Minneapolis, MN. Manufactured in: Medtronic Ireland, Galway, Ireland. Product is packaged inside a sterile, inner pouch, labeled in part "Use immediately". Inner pouch is supposed to be within a foil pouch containing desiccant, and moisture absorber. Foil pouch label reads in part "RX Endeavor Resolute Zotarolimus-Eluting Coronary Stent System...2.5 mm X 24 mm...REF IDERES25024X...Contents: One (1) Endeavor Resolute zotarolimus-eluting stent mounted on a rapid exchange stent delivery system...Guide Catheter/Minimum Inner Diameter >=5F/0.056" (1.42 mm)...Maximum Guidewire Diameter 0.014" (0.36 mm)...Maximum Stent I.D. 3.00 mm (0.12"...Nominal Pressure 9 atm (912 kPa)...Rated Burst Pressure 15 atm (1520 kPa)...MR Conditional...Sterilized using ethylene oxide Consult instructions for use...Manufacturer: Medtronic, Inc. 710 Medtronic Pkwy NE Minneapolis, MN 55432 USA...Manufactured In: Medtronic Ireland Parkmore Business Park West, Galway, Ireland Tel:+353-91-708000 Fax:+353-91-757524 Investigational Devices / Returned Goods: Tel: (800) 556-4247 / Fax: (877) 518-2469...BioLinx Medtronic Polymer System". Foil pouch contents and Instructions for Use are placed within an outer box, which is labeled identically to the foil pouch. The Endeavor Resolute System is intended for use in patients with ischemic heart disease due to stenotic lesions contained within de novo native coronary arteries with reference vessel diameters between 2.25mm and 4.2mm and lesion lengths S 27mm that are amenable to percutaneous treatment with a stent.

Recall number

Z-1367-2011

Recalling firm

Medtronic Vascular Galway Limited

Product

Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery System, UPN 00613994400505, model #IDERES25024X. Manufacturer: Medtronic, Inc. Minneapolis, MN. Manufactured in: Medtronic Ireland, Galway, Ireland. Product is packaged inside a sterile, inner pouch, labeled in part "Use immediately". Inner pouch is supposed to be within a foil pouch containing desiccant, and moisture absorber. Foil pouch label reads in part "RX Endeavor Resolute Zotarolimus-Eluting Coronary Stent System...2.5 mm X 24 mm...REF IDERES25024X...Contents: One (1) Endeavor Resolute zotarolimus-eluting stent mounted on a rapid exchange stent delivery system...Guide Catheter/Minimum Inner Diameter >=5F/0.056" (1.42 mm)...Maximum Guidewire Diameter 0.014" (0.36 mm)...Maximum Stent I.D. 3.00 mm (0.12"...Nominal Pressure 9 atm (912 kPa)...Rated Burst Pressure 15 atm (1520 kPa)...MR Conditional...Sterilized using ethylene oxide Consult instructions for use...Manufacturer: Medtronic, Inc. 710 Medtronic Pkwy NE Minneapolis, MN 55432 USA...Manufactured In: Medtronic Ireland Parkmore Business Park West, Galway, Ireland Tel:+353-91-708000 Fax:+353-91-757524 Investigational Devices / Returned Goods: Tel: (800) 556-4247 / Fax: (877) 518-2469...BioLinx Medtronic Polymer System". Foil pouch contents and Instructions for Use are placed within an outer box, which is labeled identically to the foil pouch. The Endeavor Resolute System is intended for use in patients with ischemic heart disease due to stenotic lesions contained within de novo native coronary arteries with reference vessel diameters between 2.25mm and 4.2mm and lesion lengths S 27mm that are amenable to percutaneous treatment with a stent.

Status

Terminated

Initiated

2009-08-06

Posted

2009-08-21

Terminated

2011-02-17

Reason

The product was removed from investigational sites due to a packaging issue, in that the device units were packed without the foil pouch, oxygen absorber and Instructions For Use.

Root cause

Packaging

Action

The firm, Medtronic, sent their initial "Urgent Medical Device Recall Notice" to customers with affected product via e-mail on August 7, 2009. An additional "Urgent Medical Device Recall Notice" was sent to all customers on August 12-13, 2009 via FedEX and UPS. The notice described the product, problem and action to be taken by the customers. The customers were instructed to remove the affected units from their inventory and isolate the units in a secure location to prevent additional use. A Medtronic CardioVascular Clinical Customer Service (CCS) representative will contact their site to arrange for return of the units. This will be followed by a shipment of replacement units to their sites. If there were any questions regarding the return process, customers were to contact CCS at 800-556-4247. If you have any further questions or concerns regarding this notice, please contact the Sr. Clinical Research Manager at 707-543-2284 or ann.depaoli@medtronic.com.

Quantity

49 units

Distribution

Nationwide distribution: AL, AR, CA, FL, IN, MD, MI, NY, OH, PA, RI, TX, VA, and VT.

Lot, serial or model codes

Lot Numbers:  V00265135, V00265136, V00265137, V00265139, V00265140, V00265141, V00265142, V00265143, V00265144, V00265145, V00265146, V00265147, V00265148, V00265149, V00265150, V00265151, V00265152, V00265153, V00265154, V00265155, V00265156, V00265157, V00265158, V00265159, V00265160, V00265161, V00265169, V00265170, V00265171, V00265177, V00265178, V00265179, V00265180, V00265181, V00265182, V00265183, V00265188, V00265189, V00265190, V00265191, V00265194, V00265195, V00265196, V00265223, V00265224, V00265232, V00265244, V00265251, V00265254

510(k) numbers

not on file

PMA numbers

not on file

Product code

NIQ

Firm FEI

3002806434

Firm city

Galway

Firm state

not on file

Firm country

Ireland

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

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