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. The hazard is a packaging/labeling issue that creates a difficulty in handling the device, which aligns with the rubric for moderate severity involving minor labeling or packaging issues without reported injuries.
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 affects grafts manufactured between April 3, 2012, and May 14, 2013, which can be identified by expiration dates between April 2017 and May 2018.
The reason for the recall is that 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 products were distributed worldwide, including nationwide in the United States and to numerous international locations.
Healthcare facilities should stop using the affected devices and contact Atrium Medical Corporation for further instructions regarding the recall.
The recalled product
- Product
- Advanta SuperSoft Grafts >or= 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.
See all 14 products in this recall →Related recalls
Same manufacturer · Atrium Medical Corporation
See all →- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- ModerateiCast Covered Stent Recalled for Unique Device Identifier Labeling Error
FDA (Devices) · 2024-10-16
- HighVascular graft component separation reported in Advanta VXT devices
FDA (Devices) · 2024-06-12
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- HighVascular Graft Recalled Due to Swivel Rod Separation Risk
FDA (Devices) · 2024-06-12
- HighAdvanta VXT vascular grafts recalled for swivel rod separation
FDA (Devices) · 2024-06-12
- HighVascular graft recalled due to slider component separation risk
FDA (Devices) · 2024-06-12
- HighADVANTA VXT vascular graft recalled for swivel rod separation
FDA (Devices) · 2024-06-12
- HighVascular Graft Recall for Component Separation in ADVANTA VXT
FDA (Devices) · 2024-06-12
- HighADVANTA VXT Vascular Graft Slider Rod Separation Recall
FDA (Devices) · 2024-06-12