Vascular graft recalled due to swivel rod separation risk
Atrium Medical Corporation is recalling FLIXENE vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. The recall affects 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: This is an FDA Class II medical device recall involving confirmed mechanical failure (swivel rod separation) in a vascular graft. Although no injuries or hospitalizations are reported, the separation of a critical surgical device poses a risk of harm to affected patients, fitting the rubric criterion for high-severity risk-of-harm products without reported injury.
Plain-English summary
Atrium Medical Corporation is recalling FLIXENE 4-7X30 2GDS GWT-GW double-ended slider GDS vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap between the two pieces.
Vascular grafts are medical devices used in surgical procedures to replace or bypass damaged blood vessels. When the swivel rod separates from the swivel core, the device may not function as intended, potentially compromising the integrity of the graft.
The recalled devices were distributed worldwide to medical facilities in the United States (including Puerto Rico) and 58 other countries. A total of 53,308 units were affected, including 11,236 units distributed in the US.
Patients who have received this device should contact their healthcare provider immediately. Healthcare providers should discontinue use of affected inventory and contact Atrium Medical Corporation for replacement instructions.
The recalled product
- Product
- FLIXENE, 4-7X30, 2GDS, GWT-GW. Double-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: 25141
- UDI-DI: 00650862251418.
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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