FLIXENE vascular graft recalled for slider separation defect
Atrium Medical recalls FLIXENE vascular grafts due to reported separation between the slider rod and swivel core. Affected grafts may fail to function properly if deployed.
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 medical device recall involving a structural defect in a high-risk vascular graft with no reported illnesses or injuries documented in the source. The separation defect could compromise device deployment and function, meeting the rubric criterion for High severity.
Plain-English summary
FLIXENE single-ended slider GDS vascular grafts manufactured by Atrium Medical Corporation are being recalled due to complaints of separation between the Slider GDS Swivel Rod and the Swivel Core, with a notable gap reported between the two components.
Vascular grafts are implantable medical devices used to restore or replace blood vessel function. If the slider rod separates from the swivel core, the graft may not deploy or function as intended, potentially compromising proper device operation.
Approximately 53,308 units have been distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units internationally across numerous countries. Healthcare facilities and patients should contact Atrium Medical Corporation for guidance on affected devices and any appropriate clinical action.
The recalled product
- Product
- FLIXENE, 7X30, 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: 25126
- UDI-DI: 00650862251265.
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.
See all 68 products in this recall →Related recalls
Same manufacturer · Atrium Medical Corporation
See all →- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- ModerateiCast Covered Stent Recalled for Unique Device Identifier Labeling Error
FDA (Devices) · 2024-10-16
- HighVascular graft component separation reported in Advanta VXT devices
FDA (Devices) · 2024-06-12
Same hazard · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
Similar recalls
- LowAtrium Flixene IFG Vascular Grafts Recalled for Label Adhesion Issue
FDA (Devices) · 2013-10-09
- ModerateAtrium Flixene Grafts Recalled Due to Difficult Tray Removal
FDA (Devices) · 2013-10-09
- HighAtrium ADVANTA VXT Vascular Graft may lack required radial support ring
FDA (Devices) · 2021-10-06
- ModerateAtrium Flixene IFG Recall Due to Label Adhesion Issue
FDA (Devices) · 2013-10-09
- ModerateAtrium Medical Recalls Advanta SST Bifurcated Grafts Due to Label Adhesion
FDA (Devices) · 2013-10-09
- ModerateAtrium Medical Recalls Advanta VXT Vascular Grafts Due to Label Adhesion
FDA (Devices) · 2013-10-09