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AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm PG Cata...

FDA Device Recall #Z-1703-2019 — Class II — April 17, 2019

Recall Summary

Recall Number Z-1703-2019
Classification Class II — Moderate risk
Date Initiated April 17, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Angiodynamics Inc. (Navilyst Medical Inc.)
Location Glens Falls, NY
Product Type Devices
Quantity 7348

Product Description

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 Ablation (MTA) System and accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not intended for cardiac use.

Reason for Recall

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

Distribution Pattern

Worldwide distribution - US Nationwide distribution and countries of AE AT AU BE CA CH CL CO CZ DE DK DZ EG ES FR GB GE GR HK IE IL IN IQ IT LB LT MC MT MX NL NZ PL PT SG TH TR TW VN ZA

Lot / Code Information

Serial Numbers: (1) 16480625 16490632 17130688 17140696 17150697 17190713 17190715 17210724 17210725 17280754 17290755 17290756 17290758 17290759 17290761 17300762 17300763 17330773 17330774 17340778 17340779 17350781 17350782 17370788 17380796 17390799 17390801 17390802 17410808 17410809 17410810 17420813 17430820 17430821 17440828 17450837 17460845 17470853 17470854 17480855 17480858 17480859 17480860 5334732 5347390 5353211 5356006 5359008 5370558 5370557 5371649 5371650 5375567 5377979 5377980 5382993 5383594 5392049 5396940 5406320 5406321 5411090 5411091 5426387 5426405 5428525 5426395 5426406 5430890 5430891 5430892 5432619 5432620 5442209 5444674 5444673 5444675 5448139 (2): 17200720 17210723 17220726 17240738 17240737 17250741 17260745 17290757 17300764 17340780 17360784 17400806 17420812 17420811 17440829 5353210 5356007 5359009 5389955 5385268 5403709 5406319 5426394 5444672 5448138

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Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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