Events

Recall of Endeavor Resolute ZotarolimusEluting Coronary Stent System with Rapid Exchange Delivery System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Vascular Galway Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53012
  • Event Risk Class
    Class 2
  • Event Number
    Z-1367-2011
  • Event Initiated Date
    2009-08-06
  • Event Date Posted
    2009-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84457
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Coronary drug-eluting stent - Product Code NIQ
  • 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.
  • 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.

Device

Endeavor Resolute ZotarolimusEluting Coronary Stent System with Rapid Exchange Delivery System
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: AL, AR, CA, FL, IN, MD, MI, NY, OH, PA, RI, TX, VA, and VT.
  • Product Description
    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.
  • Manufacturer
    Medtronic Vascular Galway Limited

Manufacturer

Medtronic Vascular Galway Limited
  • Manufacturer Address
    Medtronic Vascular Galway Limited, Parkmore Business Park West, Galway Ireland
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA