Atrium Medical Corporation Recall 94614
Description: ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS.
Atrium Medical Corporation Recall 94614 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1989-2024 |
| Event ID | 94614 |
| Event Description | ADVANTA VXT, 6X80, 1GDS, FH, STR-TW. Single-Ended Slider GDS. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide 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, PR, PT, PY, RO, RU, SA, SE, SG, SI, SV, TH, TN, TR, TW, UA, VN, XK, YE, ZA. |
| Quantity | 53,308 units (US: 11, 236; OUS: 42,072) |
| Recall Reason | Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces. |
| Device Classification | 20240612 |
| Device Code Info | Product Code: 22225; UDI-DI: 00650862222258. |
| Center Classification Date | 20240604 |
| Recall Initiation Date | 20240503 |
| Recalling Firm | Atrium Medical Corporation |
| Initial Notification | Letter |
| Similar To |