FDA Device recall Z-1702-2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010
- FDA Device
- Class II
- terminated
- Published 2019-06-12
On 2019-06-12 the FDA classified a Class II recall of AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010 by Angiodynamics Navilyst Medical, citing updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1702-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-17 |
| Published | 2019-06-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Angiodynamics Navilyst Medical |
| Distribution | US |
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.
Reason
Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk of potential patient harm due to a delay in performing a procedure
Identifiers
| code_info | Serial Numbers: (1) 16470624 16480627 16490631 17120679 17120680 17120681 17120682 17150698 17160702 1716070…Serial Numbers: (1) 16470624 16480627 16490631 17120679 17120680 17120681 17120682 17150698 17160702 17160703 17180710 17180711 17190712 17190714 17200716 17220734 17220735 17240736 17280752 17280753 17290760 17310767 17310768 17320770 17330775 17340776 17340777 17350783 17360786 17370787 17370789 17370791 17390798 17390800 17400803 17410807 17420815 17430819 17420818 17430822 17430824 17440825 17440831 17450832 17450833 17450834 17450835 17450836 17460838 17460839 17460841 17460840 17460842 17460843 17470851 17470852 17480856 17480857 17480861 17480862 5365914 5370556 5371648 5375252 5377978 5379637 5392050 5392051 5392052 5392053 5396938 5399659 5399855 5399856 5399857 5401850 5399859 5399858 5426382 5426386 5426383 5426404 5426384 5428527 5442207 5442208 5442212 5442211 5442213 5442214 5444677 5448140 5450578 5450579 5450845 5450844; (2): Lot/Serial Number 17200719 17220729 17220727 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1702-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.