Vascular Graft Component Separation Risk in ADVANTA VXT Models
Atrium Medical Corporation recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Patients should consult their healthcare provider regarding appropriate follow-up care.
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: This is a risk-of-harm product (vascular graft is a life-critical medical device) with a reported manufacturing defect (component separation). No illnesses or injuries have been reported, meeting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Atrium Medical Corporation is recalling 53,308 ADVANTA VXT, 7X80, 1GDS, FH, STR-SW single-ended slider GDS vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap developing between the two components.
Affected units include 11,236 devices distributed in the United States and territories, and 42,072 units distributed internationally across multiple countries. Patients who have received these devices and their healthcare providers should consult regarding appropriate follow-up care and management options.
The recalled product
- Product
- ADVANTA VXT, 7X80, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
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: 22076
- UDI-DI: 00650862220766.
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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