Medtronic Vascular Galway Limited Parkmore Business Park West Galway Ireland 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 Co Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 Co
Brand
Medtronic Vascular Galway Limited Parkmore Business Park West Galway Ireland
Lot Codes / Batch Numbers
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
Products Sold
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
Medtronic Vascular Galway Limited Parkmore Business Park West Galway Ireland is recalling Endeavor Resolute Zotarolimus-Eluting Coronary Stent System with Rapid Exchange Delivery System, UPN due to The product was removed from investigational sites due to a packaging issue, in that the device units were packed without the foil pouch, oxygen absor. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026