Atrium Medical recalls ADVANTA VXT vascular grafts with reported Slider GDS Swivel Rod separation. Affected units have specific model codes and product identifiers.
Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel Core and of a notable gap between the two pieces.
Atr: Atrium Medical is recalling specific ADVANTA VXT vascular graft models due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. This separation creates a notable gap between the two components, which could lead to complications during medical procedures.
The Slider GDS Swivel Rod can separate from the Swivel Core, creating a gap between the two parts. This separation may cause the graft to malfunction during medical procedures, potentially leading to complications.
Patients using the ADVANTA VXT vascular grafts with model codes 8X50, 1GDS, FH, STR-TW are affected. Medical professionals performing procedures with these grafts are at higher risk.
Check for product codes 8X50, 1GDS, FH, STR-TW on the ADVANTA VXT vascular grafts. The product identifier UDI-DI 00650862222142 is also associated with this recall.
Verify the model codes 8X50, 1GDS, FH, STR-TW and product identifier UDI-DI 00650862222142 on the vascular graft.
The recalled models are ADVANTA VXT with codes 8X50, 1GDS, FH, STR-TW.
Check for product codes 8X50, 1GDS, FH, STR-TW and the UDI-DI identifier 00650862222142.
The recall record does not specify a remedy, so contact Atrium Medical for guidance.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1985-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1985-2024 from Atrium Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
