Atrium Medical Vascular Graft Swivel Component Separation Recall
Atrium Medical recalled 53,308 ADVANTA VXT vascular grafts worldwide due to reported separation of the swivel rod from the swivel core. The affected units were distributed throughout the United States and to 60 additional countries.
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 of an implantable medical device with reported mechanical separation of critical components. The defect represents a risk-of-harm situation in a high-risk vascular device where component separation could affect function; no injuries have been reported.
Plain-English summary
Atrium Medical Corporation recalled the ADVANTA VXT vascular graft following complaints of separation between the Slider GDS Swivel Rod and the Swivel Core, with a notable gap observed between the two components. This vascular graft is a single-ended slider device used in medical procedures.
The recall affects 53,308 units distributed worldwide: 11,236 in the United States (including Puerto Rico) and 42,072 internationally across 60 countries. The device is identified by Product Code 22059 and UDI-DI 00650862220599.
Patients and healthcare facilities that received this device should contact Atrium Medical Corporation. Healthcare providers should identify whether affected units were implanted in patients and consult with the manufacturer regarding next steps.
The recalled product
- Product
- ADVANTA VXT, 6X40, 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: 22059
- UDI-DI: 00650862220599.
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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