Vascular graft devices recalled due to slider component separation
Atrium Medical is recalling ADVANTA VXT vascular grafts following complaints of separation between the slider component and swivel core.
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 structural defect in a medical device with no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT, 7X70, 1GDS, NH, STR-SW vascular graft devices. These single-ended slider vascular grafts are used in vascular access procedures. The recall was issued following complaints of separation of the Slider GDS Swivel Rod from the Swivel Core and a notable gap between the two pieces.
Approximately 53,308 units have been distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units outside the US across multiple countries. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- ADVANTA VXT, 7X70, 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: 22027
- UDI-DI: 00650862220278.
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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