Atrium Medical Corporation: Medical Device Recall in 2024 - (Recall #: Z-2002-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

FLIXENE, 6X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graft

Product Classification:

Class II

Date Initiated: May 3, 2024

Date Posted: June 12, 2024

Recall Number: Z-2002-2024

Event ID: 94614

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.

Status: Ongoing

Product Quantity: 53,308 units (US: 11, 236; OUS: 42,072)

Code Information:

Product Code: 25058; UDI-DI: 00650862250589.

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.

Voluntary or Mandated:

Voluntary: Firm initiated