Vascular Graft Component Separation in ADVANTA VXT Medical Devices
ADVANTA VXT vascular grafts are being recalled because the Slider GDS Swivel Rod may separate from the Swivel Core. This affects about 53,308 units distributed worldwide including the US.
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: Although classified as FDA Class II, no reported illnesses, injuries, or hospitalizations have been documented in the source text. This recall addresses a mechanical component separation that represents a risk of harm to patients with implanted devices, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Atrium Medical Corporation is recalling ADVANTA VXT 4-7X45 Single-Ended Slider GDS vascular grafts. The recall was issued due to reported separation of the Slider GDS Swivel Rod from the Swivel Core, with complaints of a notable gap developing between the two components.
The recall affects approximately 53,308 units, with 11,236 distributed in the United States (including Puerto Rico) and 42,072 distributed internationally to countries including Canada, the United Kingdom, Australia, Japan, and many others.
Patients who have received this device should contact their healthcare provider to discuss whether they need additional monitoring or device replacement. Healthcare facilities should review their inventory and follow Atrium Medical's guidance on product disposition.
The recalled product
- Product
- ADVANTA VXT, 4-7X45, 2GDS, NH, TPR-SW. Single-Ended Slider GDS. Vascular graft
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Vascular Graft
- Hazard
- device-separation
- vascular-graft-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: 22297
- UDI-DI: 00650862222975.
Distribution
Distributed nationwide across the United States.
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