Vascular graft component separation risk: ADVANTA VXT slider rod defect
Atrium Medical is recalling ADVANTA VXT vascular grafts due to reports of separation between the Slider GDS Swivel Rod and Swivel Core, potentially affecting device functionality.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with documented complaints of component separation affecting a critical component, but without reported patient injuries or illnesses. This meets the criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT, 8X70, 1GDS, FH, STR-TW single-ended slider GDS vascular grafts due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap reported between the two pieces.
This component separation could affect the device's functionality and performance. Because vascular grafts are surgical implants used in vascular access procedures, any defect affecting component integrity poses a potential risk to patient outcomes.
Approximately 53,308 units have been distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units internationally to over 90 countries and territories.
Healthcare providers who received these devices should contact Atrium Medical Corporation for guidance and instructions regarding the recall.
The recalled product
- Product
- ADVANTA VXT, 8X70, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
- Hazard
- component-separation
- device-malfunction-risk
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 (2)
- Product Code: 22222
- UDI-DI: 00650862222227.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighIntegris-Allura X-ray systems with degraded deaeration hoses recalled
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 13FR Model 94913L Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27