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 could create a gap between the two parts, potentially causing complications during medical procedures.
The hazard involves the Slider GDS Swivel Rod potentially separating from the Swivel Core, creating a gap between the two components. This separation could lead to complications during vascular procedures if the gap affects the graft's function.
Patients using the ADVANTA VXT vascular grafts with model codes 6X70, 1GDS, NH, STR-TW are affected. Medical professionals performing procedures with these grafts are at higher risk.
Check for the model codes 6X70, 1GDS, NH, STR-TW on the ADVANTA VXT vascular grafts. The product code is 22185 and UDI-DI is 00650862221855.
Verify the model codes 6X70, 1GDS, NH, STR-TW and product code 22185 on the vascular graft.
The recall is due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, but the hazard is described as low risk.
Check for model codes 6X70, 1GDS, NH, STR-TW and product code 22185 on the ADVANTA VXT vascular graft.
The recall does not specify a remedy, so check with Atrium Medical for further instructions.
We’ve drafted a message you can send Atrium Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1977-2024 — Atrium Medical Atrium Medical Hello, I own a Atrium Medical that is covered by recall Z-1977-2024 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.
