Vascular Graft Recalled Due to Potential Component Separation Risk
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to complaints of separation of the Slider GDS Swivel Rod from the Swivel Core. Over 53,000 units have been distributed worldwide.
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: This is an FDA Class II recall of a vascular graft with a reported structural defect that can cause component separation. While no illnesses or injuries have been reported in the source text, the separation of vascular graft components poses a significant risk of harm to patients.
Plain-English summary
ADVANTA VXT vascular grafts in the 4-7X80 configuration with Single-Ended Slider GDS are being recalled by Atrium Medical Corporation. These are medical devices used in vascular procedures.
The company has received complaints that the Slider GDS Swivel Rod can separate from the Swivel Core, and that a notable gap can form between the two components. This separation could potentially compromise the function of the graft.
Approximately 53,308 units have been distributed, including 11,236 units in the United States (including Puerto Rico) and 42,072 units in other countries worldwide.
Physicians and patients who have received or are considering this device should contact Atrium Medical Corporation or their healthcare provider for guidance. The FDA is working with the manufacturer on this issue.
The recalled product
- Product
- ADVANTA VXT, 4-7X80, 1GDS, FH, TPR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-separation
- device-malfunction
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: 22266
- UDI-DI: 00650862222661.
Distribution
Distributed nationwide across the United States.
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