Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG Recalled by Angiodynamics Inc. (Navilyst Medical Inc.) Due to Updated Warning Statements in the Operator's Manual/Directions for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Angiodynamics Inc. (Navilyst Medical Inc.) directly.
Affected Products
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: Solero Generator PG (1) Catalog Number:12740000 UPN: H78712740000 (2) Solero Generator US PG Catalog Number: 12740000US UPN: H78712740000US0 (3) Solero Generator Service Loaner PG Catalog No: 12740000L UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0
Quantity: 314 units
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Angiodynamics Inc. (Navilyst Medical Inc.)
Angiodynamics Inc. (Navilyst Medical Inc.) has 78 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report