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Recall Observatory FDA recall evidence

Device product

ADVANTA VXT, 8X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Z-1990-2024

May 03, 2024

Class II

Product summary

Firm
Atrium Medical Corporation
Event
Event 94614
Status
Ongoing
Classification
Class II
Quantity
53,308 units (US: 11, 236; OUS: 42,072)
Official record key
device-enforcement:Z-1990-2024

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: 22227; UDI-DI: 00650862222272.

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

    reason.no_named_rule · v1.0.0

    Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.