Vascular Graft Recalled Due to Swivel Rod Separation Risk
Atrium Medical is recalling ADVANTA VXT vascular grafts worldwide due to complaints of the swivel rod separating from the core, which could compromise device function during medical procedures.
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 3/5 (High).
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 recall involving structural defects in a high-risk vascular graft used in surgical procedures. While no illnesses or injuries have been reported in the source, the separation of critical components poses a risk of harm during use, meeting the criteria for high severity.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT, 6X45, 1GDS, CH, STR-SW vascular grafts (product code 22092) due to reports of separation between the swivel rod and swivel core, and a notable gap between these components.
The affected units were distributed worldwide, including throughout the United States and Puerto Rico, and to numerous international markets. A total of 53,308 units have been identified as part of this recall.
This structural defect could potentially compromise graft function during vascular surgical procedures. Healthcare providers and patients who have received these grafts should contact their healthcare provider for guidance. Atrium Medical has been notified of the separation issues and is working with healthcare providers on appropriate management of affected devices.
The recalled product
- Product
- ADVANTA VXT, 6X45, 1GDS, CH, STR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
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: 22092
- UDI-DI: 00650862220926.
Distribution
Part of a larger recall action
This product is one of 68 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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