AngioDynamics Solero Microwave Tissue Ablation (MTA) System
Medical device recall Z-1701-2019. 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
- 178 units 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 Generator Refurbished PG Catalog Number: 12740000D UPN: H78712740000D0 (2) Solero Generator Refurbished US PG Catalog Number: 12740000USD ;UPN: H78712740000USD0
178 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: (1) QBY0002025 QBY0002027 QBY0001994 QBY0001993 QBY0002001 QBY0002006 QBY0002008 QBY0002002 QBY0002003 QBY0002007 QBY0002010 QBY0002004 QBY0002036 QBY0002040 QBY0002042 QBY0002044 QBY0002039 QBY0002035 QBY0002034 QBY0002033…
Every code shown here, 1,971 characters
Serial Numbers: (1) QBY0002025 QBY0002027 QBY0001994 QBY0001993 QBY0002001 QBY0002006 QBY0002008 QBY0002002 QBY0002003 QBY0002007 QBY0002010 QBY0002004 QBY0002036 QBY0002040 QBY0002042 QBY0002044 QBY0002039 QBY0002035 QBY0002034 QBY0002033 QBY0002026 QBY0002041 QBY0002037 QBY0002051 QBY0002052 QBY0002055 QBY0002054 QBY0002058 QBY0002056 QBY0002301 QBY0002059 QBY0002311 QBY0002352 QBY0002429 QBY0002478 QBY0002529 QBY0002628 QBY0002695 QBY0002696 QBY0002698 QBY0002710 QBY0002711 QBY0002740 QBY0002742 QBY0002741 QBY0002778 QBY0002795 QBY0002820 QBY0002818 QBY0002811 QBY0002834 QBY0002827 QBY0002828 QBY0002829 QBY0002830 QBY0002831 QBY0002836 QBY0002838 QBY0002843 QBY0002844 QBY0002859 QBY0002860 QBY0002926 QBY0002927 QBY0002936 QBY0002909 QBY0002935 QBY0002937 QBY0002938 QBY0003040 QBY0003162 QBY0003185 QBY0003215 QBY0003216 QBY0003135 QBY0003137 QBY0003141 (2) Lot/Serial Number QBY0002279 QBY0002294 QBY0002295 QBY0002293 QBY0002305 QBY0002284 QBY0002280 QBY0002299 QBY0002298 QBY0002296 QBY0002278 QBY0002290 QBY0002287 QBY0002281 QBY0002289 QBY0002277 QBY0002285 QBY0002378 QBY0002377 QBY0002384 QBY0002380 QBY0002386 QBY0002387 QBY0002388 QBY0002394 QBY0002390 QBY0002392 QBY0002391 QBY0002396 QBY0002398 QBY0002395 QBY0002399 QBY0002472 QBY0002482 QBY0002483 QBY0002484 QBY0002485 QBY0002518 QBY0002521 QBY0002522 QBY0002524 QBY0002525 QBY0002528 QBY0002535 QBY0002536 QBY0002537 QBY0002538 QBY0002539 QBY0002540 QBY0002541 QBY0002544 QBY0002550 QBY0002551 QBY0002561 QBY0002562 QBY0002567 QBY0002568 QBY0002577 QBY0002578 QBY0002579 QBY0002580 QBY0002614 QBY0002617 QBY0002620 QBY0002621 QBY0002667 QBY0002666 QBY0002681 QBY0002685 QBY0002686 QBY0002688 QBY0002689 QBY0002691 QBY0002692 QBY0002693 QBY0002705 QBY0002706 QBY0002707 QBY0002708 QBY0002760 QBY0002835 QBY0002761 QBY0002888 QBY0002891 QBY0002892 QBY0002959 QBY0003220 QBY0003221 QBY0003225 QBY0003227 QBY0003228 QBY0003229 QBY0003230 QBY0003231 QBY0003311 QBY0003321; (2) QBY0002306 QBY0002616
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.