Recall Z-1297-2014 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Trivascular, Inc
Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc. 3910 Brickway Blvd. Santa Rosa, CA 95403 The TriVascular Ovation Prime Abdominal Stent Graft System is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isola
| Date | Mar 26, 2014 (initiated Feb 27, 2014) |
| Status | Terminated |
| Reason | Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to notify them of changes to Instructions for Use. |
| Root cause | Device Design |
| Action | Trivascular sent an Important Medical Device Information letter dated February 27, 2014, to all European physicians who have scheduled cases through March 31, 2014 or until IFU;s are translated and available for European physicians. The letter provided notification of an update that will appear in a future revision of the product Instructions for Use (IFU). The IFU will be available in their country when the required translations and product registration/notification have been completed. This IFU does not require rework or return of the affected product. Customers with questions were instr |
| Quantity | 45 |
| Distribution | Worldwide Distribution including Austria, Belgium, Czech Republic, France, Germany, Greece, Hungary, Italy, Luxembourg, Norway, Poland, Spain, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.