Vascular Graft Component Separation Recall - Atrium Medical ADVANTA VXT
Atrium Medical Corporation is recalling the ADVANTA VXT vascular graft due to reported separation of the Swivel Rod from the Swivel Core. The component separation poses a risk of device failure.
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 an FDA Class II recall of a medical device with documented mechanical separation of a critical structural component. While no injuries or illnesses are reported in the source, the failure of a vascular graft component poses a potential risk of device failure during clinical use.
Plain-English summary
Atrium Medical Corporation is recalling the ADVANTA VXT vascular graft following complaints of separation of the Slider GDS Swivel Rod from the Swivel Core, with a notable gap between the two pieces. The device is used in vascular procedures, and this component separation could affect device performance.
Approximately 53,308 units were distributed worldwide, including 11,236 units in the United States and Puerto Rico, and 42,072 units in international markets spanning multiple countries. The product code is 22116 (UDI-DI: 00650862221169).
The FDA has classified this as a Class II recall. Patients and healthcare providers who may be affected by this component separation should seek information from Atrium Medical Corporation or their healthcare provider.
The recalled product
- Product
- ADVANTA VXT, 5-8X45, 1GDS, NH, TPR-SW. 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: 22116
- UDI-DI: 00650862221169.
Distribution
Distributed nationwide across the United States.
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