ADVANTA VXT, 8X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft

FDA device recall Z-1961-2024 · posted 2024-06-04 · Open, Classified

Recall details

Recalling firm

Atrium Medical Corporation

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.

Action taken

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.

Root cause

Equipment maintenance

Status

Open, Classified

Product code

DSY

Quantity affected

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, I

Date initiated

2024-05-03

Date posted

2024-06-04

Location

Merrimack, NH

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