Vascular graft recalled for swivel rod separation risk
FDA recalls Atrium Medical's FLIXENE vascular grafts due to reports of the swivel rod separating from the core, potentially compromising device integrity.
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 a vascular graft involving a reported structural defect (swivel rod separation) in a high-risk medical device. Although no injuries or deaths have been reported, the potential for serious harm is significant given the device's use in critical cardiovascular procedures.
Plain-English summary
Atrium Medical Corporation is recalling the FLIXENE 6X50 single-ended slider GDS vascular graft following complaints that the Slider GDS Swivel Rod can separate from the Swivel Core. This separation creates a structural gap in the device.
A total of 53,308 units have been distributed: 11,236 in the United States (including Puerto Rico) and 42,072 to countries including Canada, Australia, Germany, France, Japan, China, and many others.
Vascular grafts are used in cardiovascular surgery. A separation of the swivel rod from the core creates a structural defect that could affect device function. The FDA classified this as a Class II recall.
Patients who have received this device should consult with their healthcare provider about potential risks. Healthcare facilities should immediately stop using remaining inventory and contact Atrium Medical Corporation for further guidance.
The recalled product
- Product
- FLIXENE, 6X50, 1GDS, STR. 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: 25052
- UDI-DI: 00650862250527.
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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