Vascular graft component separation in Atrium Medical ADVANTA VXT devices
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts worldwide due to reports of separation between the swivel rod and swivel core. The component failure could affect graft function.
What this means for you
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 classified as FDA Class II. The source contains no reports of illnesses or injuries, only complaints of component separation. The hazard involves risk of harm in a critical-use vascular graft, matching the High severity criterion for risk-of-harm products without reported injury.
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT single-ended slider GDS vascular grafts worldwide due to reports of separation between the Slider GDS Swivel Rod and the Swivel Core. Affected units show a notable gap between these two components, which could compromise the structural integrity and proper function of the graft.
The recall affects 53,308 units total, with 11,236 distributed in the United States including Puerto Rico, and 42,072 distributed worldwide to numerous countries including Austria, Belgium, Brazil, Canada, China, France, Germany, Japan, Mexico, the Netherlands, and others.
The FDA has classified this as a Class II recall. Healthcare providers with affected inventory should review the recall details and guidance provided by the manufacturer.
The recalled product
- Product
- ADVANTA VXT, 8X40, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular graft
- Hazard
- component-separation
- device-failure
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: 22170
- UDI-DI: 00650862221701.
Distribution
Distributed nationwide across the United States.
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