AngioDynamics Solero Microwave Tissue Ablation System Recall for Procedure Delay Risk
AngioDynamics is recalling 1,846 Solero Microwave Tissue Ablation System applicators to reduce 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, which fits the rubric for high-risk products where injury has not yet been reported.
Plain-English summary
AngioDynamics Inc. (Navilyst Medical Inc.) is recalling 1,846 units of the Solero Microwave Tissue Ablation (MTA) System applicators, specifically the 29cm PG models with catalog numbers 700106003 and 700106003US. 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 affected products are indicated for the ablation of soft tissue during open procedures and are not intended for cardiac use. The recall covers units distributed worldwide, including the United States and numerous international markets. Specific serial numbers for the affected units are listed in the official recall documentation.
Healthcare providers and facilities should stop using the affected applicators and contact the manufacturer for instructions on obtaining the updated manual and software. Patients who have undergone procedures using these devices should consult their healthcare provider if they have concerns regarding the timing of their treatment.
The recalled product
- Product
- AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 Product Usage: The Solero Microwave Tissue Ablation
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 1,846
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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