AngioDynamics Solero Microwave Tissue Ablation System Recall for Delayed Procedures
AngioDynamics is recalling 314 Solero Microwave Tissue Ablation System generators 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 involves a risk-of-harm product (medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
AngioDynamics Inc. (Navilyst Medical Inc.) is recalling 314 units of the Solero Microwave Tissue Ablation (MTA) System generators. The affected units include the Solero Generator PG, Solero Generator US PG, Solero Generator Service Loaner PG, and Solero Generator Service Loaner US PG. These devices were distributed worldwide, including across 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 corrective actions are intended to reduce the risk of potential patient harm caused by a delay in performing a procedure. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities and users should check their device serial numbers against the list provided in the official recall notice. Affected users should contact AngioDynamics Inc. for instructions on obtaining the necessary software updates and manual revisions.
The recalled product
- Product
- 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
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 314
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- (3) QBY0002361
- (4) QBY0002306 QBY0002616
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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