Vascular graft component separation reported in FLIXENE Slider GDS devices
Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation between the Slider GDS Swivel Rod and Swivel Core, affecting 53,308 units distributed 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: FDA Class II medical device recall for mechanical component separation in a vascular graft. No injuries or illnesses are reported. This qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Atrium Medical Corporation is recalling the FLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS vascular graft due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Users have reported a notable gap forming between these two components.
The separation of the swivel rod from the swivel core could potentially affect the integrity and function of the vascular graft. Approximately 53,308 units have been distributed worldwide, including 11,236 units in the United States and 42,072 units in countries outside the United States.
Healthcare facilities and practitioners who have received these devices should stop using affected units immediately and verify product codes against the recall notice. Contact Atrium Medical Corporation for instructions on device return or replacement. Patients who have received these devices should consult their healthcare provider about appropriate next steps.
For more information, contact Atrium Medical Corporation or the FDA.
The recalled product
- Product
- FLIXENE, 7X80, 1GDS, GW. 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: 25120
- UDI-DI: 00650862251203.
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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