AngioDynamics Solero Microwave Tissue Ablation — Class II medical device recall Z-1704-2019
Terminated recall by Angiodynamics Inc. (Navilyst Medical Inc.), reported 2019-06-12, distributed nationwide. Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the risk
| Recall number | Z-1704-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.), Glens Falls, NY, United States |
| Recall initiated | 2019-04-17 |
| Classified | 2019-05-31 |
| Reported by FDA | 2019-06-12 |
| Terminated | 2020-06-09 |
| Distributed | Nationwide (US) |
| Quantity | 1,846 |
| Reason classes | software |
| Serial numbers | 16480626, 17150699, 17160704, 17170705, 17170706, 17200721, 17210722, 17220730, 17220731, 17220732, 17250743, 17270749, 17300765, 17310766, 17320771, 17370790, 17380794, 17380795, 17390797, 17400805, 17420814, 17420816, 17420817, 17430823, 17440830 and 13 more |
| Model numbers | 700106003, 700106003US, H7877001060030 |
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 for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1704-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.