Medtronic Vascular, Inc. Recall 88951
Description: Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Medtronic Vascular, Inc. Recall 88951 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0290-2022 |
| Event ID | 88951 |
| Event Description | Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE |
| Product Type | Devices |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom. |
| Quantity | 2 devices |
| Recall Reason | During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube |
| Device Classification | 20211201 |
| Device Code Info | Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639 |
| Center Classification Date | 20211124 |
| Recall Initiation Date | 20211015 |
| Recalling Firm | Medtronic Vascular, Inc. |
| Initial Notification | Letter |
| Similar To |