Reported Jun 12, 2019 · Terminated
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN:…
Angiodynamics Inc. (Navilyst Medical Inc.)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Angiodynamics Inc. (Navilyst Medical Inc.) · 10 Glens Falls Tech Park · Glens Falls, NY · 12801-3864
Is this the product you have?
- AngioDynamics Solero
- Microwave Tissue Ablation (MTA) System(1)Solero
- Applicator 29cm PG Catalog Number700106003
- UPNH7877001060030 (2)Solero
- Applicator 29cm PG US Catalog Number700106003US
- UPNH787700106003US0
- Product UsageThe 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
- Lot codes and dates
- Serial Numbers(1)(2)
1648062617150699171607041717070517170706173107661737079017380795173907971742081417420817174308231746084417460847174708505377356
172007211721072217220730172207311722073217250743172707491730076517320771173807941740080517420816174408301747084953465965355835538526753920555392056541659054264075446902
- Serial Numbers(1)
- Amount recalled
- 1846
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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