Atrium Medical Corporation: ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Recall number

Z-1983-2024

Recalling firm

Atrium Medical Corporation

Product

ADVANTA VXT, 6X50, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft

Status

Open, Classified

Initiated

2024-05-03

Posted

2024-06-04

Terminated

not on file

Reason

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

Root cause

Equipment maintenance

Action

Consignees were sent an URGENT MEDICAL DEVICE- REMOVAL notification by mail, dated 5/3/24. Consignees are instructed to examine their inventory immediately to determine if any recalled product is in their possession. Recalled product possesses the REF number on device labeling and has an expiration date prior to 24FEB2027. All consignees are asked to complete and return the provided response form by email to GDSgrafts2024@getinge.com or by fax to 1-866-560-4062. Consignees that are distributors are asked to forward the provided notification to their customers. Consignees are to post a copy of the recall notification in all inventory locations where affected devices are stored and ensure all appropriate personnel are aware. If consignees possess recalled devices, they are to contact their local Atrium/Getinge Customer Support Department at 888-943-8872 (option 2) to receive instructions for returning any affected devices. The recalling firm will provide replacement product within 5-8 weeks of return of devices. The recalling firm states that if there is a medical need to use the device and no alterative device is available, then the graft may be used per the provided instructions. Customers can contact Customer support with any questions at 888-943-8872 (option 2) from Monday through Friday, between 8:00 AM and 6:00 PM.

Quantity

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

Distribution

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.

Lot, serial or model codes

Product Code: 22212; UDI-DI: 00650862222128.

510(k) numbers

["K992960"]

PMA numbers

not on file

Product code

DSY

Firm FEI

3011175548

Firm city

Merrimack

Firm state

NH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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