AngioDynamics Solero Microwave Tissue Ablation — Class II medical device recall Z-1703-2019
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-1703-2019 |
|---|---|
| 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 | 7,348 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00787700106002 |
| Serial numbers | 16480625, 16490632, 17130688, 17140696, 17150697, 17190713, 17190715, 17200720, 17210723, 17210724, 17210725, 17220726, 17240737, 17240738, 17250741, 17260745, 17280754, 17290755, 17290756, 17290757, 17290758, 17290759, 17290761, 17300762, 17300763 and 78 more |
| Model numbers | 700106002, 700106002US, H7877001060020, H787700106002US0 |
Product
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002 UPN: H7877001060020 (2)Solero Applicator 19cm PG US Catalog Number:700106002US UPN: H787700106002US0 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-1703-2019. 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.