Device product
FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Z-2003-2024
Product summary
- Event
- Event 94614
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 53,308 units (US: 11, 236; OUS: 42,072)
- Official record key
device-enforcement:Z-2003-2024
Official wording
Reason: Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Code information: Product Code: 25059; UDI-DI: 00650862250596.
Distribution pattern: Worldwide distribution - US Nationwide including Puerto Rico, and the countries of AE, AR, AT, AU, BE, BG, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IQ, IT, JO, JP, KR, KW, LT, LU, LV, ME, MN, MU, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PH, PK, PL, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA.
Derived failure modes
-
Unknown
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.