| Class 2 Device Recall Endeavor Resolute ZotarolimusEluting Coronary Stent System with Rapid Exchange Delivery System | |
Date Initiated by Firm | August 06, 2009 |
Date Posted | August 21, 2009 |
Recall Status1 |
Terminated 3 on February 17, 2011 |
Recall Number | Z-1367-2011 |
Recall Event ID |
53012 |
Product Classification |
Coronary drug-eluting stent - Product Code NIQ
|
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. |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Medtronic Vascular Galway Limited Parkmore Business Park West Galway Ireland
|
For Additional Information Contact | Sarah Shepard 707-591-7465 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | 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 in Commerce | 49 units |
Distribution | Nationwide distribution: AL, AR, CA, FL, IN, MD, MI, NY, OH, PA, RI, TX, VA, and VT. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|