FDA Device recall Z-1704-2019
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)S…
- 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 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)S… 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-1704-2019 |
| 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 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 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) 16480626 17150699 17160704 17170705 17170706 17310766 17370790 17380795 17390797 1742081…Serial Numbers: (1) 16480626 17150699 17160704 17170705 17170706 17310766 17370790 17380795 17390797 17420814 17420817 17430823 17460844 17460847 17470850 5377356 (2) 17200721 17210722 17220730 17220731 17220732 17250743 17270749 17300765 17320771 17380794 17400805 17420816 17440830 17470849 5346596 5355835 5385267 5392055 5392056 5416590 5426407 5446902 |
|---|
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-1704-2019%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.