Recall Z-1367-2011 ยท NIQ Coronary Drug-Eluting Stent
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,
| Date | Aug 21, 2009 (initiated Aug 6, 2009) |
| Status | Terminated |
| 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 ar |
| Quantity | 49 units |
| Distribution | Nationwide distribution: AL, AR, CA, FL, IN, MD, MI, NY, OH, PA, RI, TX, VA, and VT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.