Recall Z-2263-2020 ยท MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Endologix, Inc.
Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J
| Date | Jun 11, 2020 (initiated May 6, 2020) |
| Status | Terminated |
| Reason | A material weakness adjacent to the polymer fill channel may become compromised during pressurization with liquid polymer. Polymer leaks may occur during implantation of abdominal stent graft system. Clinical events related to polymer leaks may be systemic and/or aneurysm related. |
| Root cause | Process control |
| Action | On 05/06/20, "Urgent Medical Device Correction notices" were distributed to customers via person/mail/email. These notices reaffirmed treatment recommendations for patients provided in the previously distributed Urgent Field Safety Notice, dated 09/26/2018 that were mailed on 09/27/18. Safety Update: Treatment of a Patient with Polymer Leak - Patient Reaction During the polymer injection step of the procedure, systemic hypotension may indicate that a polymer leak is occurring. Blood pressure monitoring during polymer fill may assist in early identification of a potential polymer leak. In t |
| Quantity | 9156 |
| Distribution | Worldwide DIstribution: U.S (nationwide).: PA, AZ, NY, FL, HI, CA, OR, IL, MS, AR, WI, KY, TX, TN, MO, NJ, MA, MT, VA, MI, CO, WV, NC, NH, NV, CT, ME, WY, OH, OK, IN, UT, AL, WA, GA, SC, KS, LA, NM, MD, DC, NE, SD, RI, IA, VT, ND. and Countries of:: Argentina, Australia, Chile, Hong Kong, Japan, Mal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.