Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Reported: October 6, 2021 Initiated: August 25, 2021 #Z-2589-2021
Product Description
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Reason for Recall
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
Details
- Recalling Firm
- Atrium Medical Corporation
- Units Affected
- 28 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Florida and the countries of South Korea and Poland.
- Location
- Merrimack, NH
Frequently Asked Questions
What product was recalled? ▼
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.. Recalled by Atrium Medical Corporation. Units affected: 28 units.
Why was this product recalled? ▼
The product package may potentially contain a mismatched graft that does not contain the radial support ring (helix) identified in the labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 6, 2021. Severity: Moderate. Recall number: Z-2589-2021.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11