Reported Oct 6, 2021 · Terminated
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial…
Atrium Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atrium Medical Corporation · 40 Continental Blvd · Merrimack, NH · 03054-4332
Is this the product you have?
- Atrium ADVANTA VXT Vascular Graft, Part No. 22059
- UDI 00650862220599 - Product Usageintended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access
- Lot codes and dates
- Lot 458755 Serial numbers
458755001458755007458755013458755019458755025458755002458755008458755014458755020458755026458755003458755009458755015458755021458755027458755004458755010458755016458755022458755028458755005458755011458755017458755023458755029458755006458755012458755018458755024458755030
- Lot 458755 Serial numbers
- Amount recalled
- 28 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- FL
Why it was recalled
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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