Vascular graft slider component separation poses implant failure risk
Atrium Medical is recalling ADVANTA VXT vascular grafts due to separation of the slider swivel rod from its core. This structural defect could lead to device failure. Over 53,000 units are affected worldwide.
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 an FDA Class II recall involving a confirmed structural defect in a critical surgical implant device. The separation of the slider mechanism poses a real risk of device failure in vascular grafts. No hospitalizations or injuries have been reported, placing this in the category of risk-of-harm products where patient impact has not yet been documented.
Plain-English summary
The FDA is notifying consumers of a Class II recall of ADVANTA VXT vascular grafts manufactured by Atrium Medical Corporation. These single-ended slider devices are used in vascular surgery to create or repair blood vessel access. The recall affects approximately 53,308 units, including 11,236 units distributed in the United States and 42,072 units internationally.
The defect involves separation of the slider GDS swivel rod from the swivel core, with reports of a notable gap between the two components. This separation could compromise the structural integrity and function of the device during or after implantation.
The recalled devices were distributed worldwide, including across all US states and territories as well as to 68 other countries. Patients who received these grafts should consult with their healthcare team or contact Atrium Medical Corporation regarding their implanted devices and whether further evaluation is needed.
The recalled product
- Product
- ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. 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: 22025
- UDI-DI: 00650862220254.
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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