ADVANTA VXT Vascular Grafts Recalled for Slider Component Separation Risk
Atrium Medical Corporation is recalling ADVANTA VXT vascular grafts due to reported separation of the Slider GDS Swivel Rod from the Swivel Core. Approximately 53,308 units worldwide are affected.
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 vascular graft with confirmed reports of component separation. While no injuries or hospitalizations have been reported in the source text, separation of internal device components in a high-risk medical device represents a significant risk of harm, matching the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
ADVANTA VXT vascular grafts, manufactured by Atrium Medical Corporation, are being recalled due to reported separation of internal components. The product is a single-ended slider GDS (graft deployment system) vascular graft used in cardiovascular procedures.
The FDA has received complaints of separation between the Slider GDS Swivel Rod and the Swivel Core, with notable gaps observed between these components. This separation may affect the proper deployment or function of the device.
The recall affects approximately 53,308 units distributed worldwide, including 11,236 units in the United States and Puerto Rico and 42,072 units internationally across numerous countries. Healthcare facilities should review their inventory and contact the manufacturer for further guidance.
The recalled product
- Product
- ADVANTA VXT, 4-7X70, 1GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- component-separation
- device-malfunction
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: 22117
- UDI-DI: 00650862221176.
Distribution
Distributed nationwide across the United States.
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