AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedure Risk
AngioDynamics is recalling Solero Microwave Tissue Ablation System applicators to reduce the risk of patient harm from delayed procedures via manual and software updates.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of patient harm due to procedural delays, but the source text does not report any specific injuries, hospitalizations, or fatalities, placing it in the High severity category.
Plain-English summary
AngioDynamics Inc. (Navilyst Medical Inc.) is recalling the Solero Microwave Tissue Ablation (MTA) System applicators, specifically the 14cm PG models with catalog numbers 700106001 and 700106001US. The recall involves 10,580 units distributed worldwide, including the United States and numerous international markets.
The recall is being conducted to update the Warning Statements in the Operator's Manual/Directions for Use and to provide software updates. These measures are intended to reduce the risk of potential patient harm resulting from a delay in performing a procedure. The Solero MTA System is indicated for the ablation of soft tissue during open procedures and is not intended for cardiac use.
Healthcare providers and facilities that have received these specific applicators should contact the manufacturer for instructions on obtaining the updated documentation and software. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 Product Usage: The Solero Microwave Tissue Ablat
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 10,580
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Angiodynamics Inc. (Navilyst Medical Inc.) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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