Reported Jun 12, 2019 · Terminated
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Catalog Number: 700106002…
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 19cm PG Catalog Number700106002
- UPNH7877001060020 (2)Solero
- Applicator 19cm PG US Catalog Number700106002US
- UPNH787700106002US0
- 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):
78 of 78 codes
1648062516490632171306881714069617150697171907131719071517210724172107251728075417290755172907561729075817290759172907611730076217300763173307731733077417340778173407791735078117350782173707881738079617390799173908011739080217410808174108091741081017420813174308201743082117440828174508371746084517470853174708541748085517480858174808591748086053347325347390535321153560065359008537055853705575371649537165053755675377979537798053829935383594539204953969405406320
1720072017210723172207261724073817240737172507411726074517290757173007641734078017360784174008061742081217420811174408295353210535600753590095389955538526854037095406319542639454446725448138
- Serial Numbers(1)
- Amount recalled
- 7348
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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