Atrium Medical Recalls Advanta SuperSoft Grafts Due to Label Adhesion
Atrium Medical Corporation is recalling Advanta SuperSoft Grafts because the inner tray label may adhere to the outer tray, making it difficult to remove the tray onto the sterile field.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect involves a packaging/labeling issue (label adhesion) that makes removal difficult rather than a direct contamination or structural failure causing immediate harm. This aligns with the 'Moderate' criteria for minor labeling/packaging issues or voluntary precautionary recalls where no direct injury is reported.
Plain-English summary
Atrium Medical Corporation is recalling Advanta SuperSoft Grafts, which are intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. The recall is due to a defect where the inner tray label may adhere to the wall of the outer tray. This adhesion makes it difficult to remove the tray onto the sterile field.
The affected products were manufactured between April 3, 2012, and May 14, 2013. These units can be identified by their expiration dates, which range between April 2017 and May 2018. The products were distributed worldwide, including nationwide in the United States and to numerous international locations.
Healthcare providers and facilities should stop using the affected grafts and contact Atrium Medical Corporation for instructions on how to return the product. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Grafts
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Product manufactured between April 3
- 2012 and May 14
- 2013 and can be identified by their expiration date
- between April 2017 and May 2018.
Distribution
Part of a larger recall action
This product is one of 14 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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