Atrium Medical Corporation: Device Recall

Recall Details

Recall Number

Z-1998-2024

Classification

Class II

Product Type

Device

Recalling Firm

Atrium Medical Corporation

Status

Ongoing

Date Initiated

05/03/2024

Location

Merrimack, NH, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

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

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.

Product Description

ADVANTA VXT, 4-6X45, 1GDS, CH, TPR-SW. Single-Ended Slider GDS. Vascular graft

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.

Other Recalls by Atrium Medical Corporation

• Class II: Risk 09/09/2024
  There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
• Class II: Risk 05/03/2024
  Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
• Class II: Risk 05/03/2024
  Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
• Class II: Risk 05/03/2024
  Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
• Class II: Risk 05/03/2024
  Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.

View all recalls by Atrium Medical Corporation →