Z-1980-2024 Class II Ongoing
FDA device recall Z-1980-2024 was initiated by Atrium Medical Corporation on May 3, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 53,308 units (US: 11, 236; OUS: 42,072).
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2024
- Initiation Date
- May 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53,308 units (US: 11, 236; OUS: 42,072)
Product Description
ADVANTA VXT, 6X80, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
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 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.
Code Information
Product Code: 22190; UDI-DI: 00650862221909.