Medical Device Recall: FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graft
Atrium Medical Corporation · May 3, 2024
Reason for Recall
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
53,308 units (US: 11, 236; OUS: 42,072)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2006-2024
Status: ongoing
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