FDA-Device2024-06-12Class II
ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Atrium Medical Corporation
Hazard
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Sold states
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.
Affected count
53,308 units (US: 11, 236; OUS: 42,072)
Manufactured in
40 Continental Blvd, N/A, Merrimack, NH, United States
Products
ADVANTA VXT, 8X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1985-2024Don't want to check this manually?
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