AngioDynamics Solero Microwave Tissue Ablation (MTA) System
Medical device recall Z-1702-2019. Published in FDA’s Enforcement Report on Jun 12, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 12, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 10580 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
10580, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,269 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 17, 2019.
- FDA classified it on May 31, 2019.
- FDA’s Enforcement Report published it on Jun 12, 2019.
- FDA terminated it on Jun 9, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Angiodynamics Inc. (Navilyst Medical Inc.), of Glens Falls, NY.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.