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AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Cat...

FDA Device Recall #Z-1702-2019 — Class II — April 17, 2019

Recall Summary

Recall Number Z-1702-2019
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 10580

Product Description

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1) Solero Applicator 14cm PG Catalog Number: 700106001 UPN:H7877001060010; (2)Solero Applicator 14cm PG US Catalog Number:700106001US UPN: H787700106001US0 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) 16470624 16480627 16490631 17120679 17120680 17120681 17120682 17150698 17160702 17160703 17180710 17180711 17190712 17190714 17200716 17220734 17220735 17240736 17280752 17280753 17290760 17310767 17310768 17320770 17330775 17340776 17340777 17350783 17360786 17370787 17370789 17370791 17390798 17390800 17400803 17410807 17420815 17430819 17420818 17430822 17430824 17440825 17440831 17450832 17450833 17450834 17450835 17450836 17460838 17460839 17460841 17460840 17460842 17460843 17470851 17470852 17480856 17480857 17480861 17480862 5365914 5370556 5371648 5375252 5377978 5379637 5392050 5392051 5392052 5392053 5396938 5399659 5399855 5399856 5399857 5401850 5399859 5399858 5426382 5426386 5426383 5426404 5426384 5428527 5442207 5442208 5442212 5442211 5442213 5442214 5444677 5448140 5450578 5450579 5450845 5450844; (2): Lot/Serial Number 17200719 17220729 17220727 17220728 17220733 17240739 17250740 17250742 17260744 17260746 17270748 17270750 17280751 17320769 17320772 17360785 17380792 17380793 17400804 17440827 17440826 17470848 5341431 5347402 5347400 5349199 5353212 5356008 5359010 5361185 5389956 5379727 5396939 5394387 5394388 5398904 5404489 5426396 5428526 5426393 5430888 5430889 5426385 5442210 5444676 5448137 5448135

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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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