AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures
AngioDynamics is recalling 7,348 Solero Microwave Tissue Ablation applicators to update manuals and software, reducing the risk of patient harm from procedure delays.
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 procedure delays, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
AngioDynamics Inc. (Navilyst Medical Inc.) is recalling 7,348 units of the Solero Microwave Tissue Ablation (MTA) System applicators. The affected products include the Solero Applicator 19cm PG (Catalog Number 700106002) and the Solero Applicator 19cm PG US (Catalog Number 700106002US). These devices are indicated for the ablation of soft tissue during open procedures and are not intended for cardiac use.
The recall is being conducted to update the warning statements in the Operator's Manual/Directions for Use and to provide software updates. These changes are intended to reduce the risk of potential patient harm resulting from a delay in performing a procedure. The agency has classified this as a Class II recall.
The affected units were distributed worldwide, including nationwide distribution in the United States and in numerous other countries such as Australia, Canada, Germany, and the United Kingdom. Healthcare providers and facilities that have these specific serial numbers should contact the manufacturer for instructions on obtaining the updated manuals and software.
The recalled product
- 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 Ablati
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 7,348
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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