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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82743

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 17, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Angiodynamics Inc. (Navilyst Medical Inc.)

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

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 UPN: H78712740000L0 (4) Solero Generator Service Loaner US PG Catalog Number: 12740000USL UPN: H78712740000USL0

Z-1700-2019
Recall number
Z-1700-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Quantity
314 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

Serial Numbers: (1) QBY0002022 QBY0001996 QBY0001997 QBY0002018 QBY0002303 QBY0002031 QBY0002020 QBY0002032 QBY0002016 QBY0002208 QBY0002017 QBY0002019 QBY0001990 QBY0002000 QBY0001989 QBY0001991 QBY0001995 QBY0001992 QBY0002024 QBY0001998 QBY0001999 QBY0002023 QBY0002012 QBY0002013 QBY0002009 QBY0002015 QBY0002014 QBY0002005 QBY0002011 QBY0002045 QBY0002046 QBY0002047 QBY0002048 QBY0002049 QBY0002050 QBY0002210 QBY0002209 QBY0002057 QBY0002304 QBY0002302 QBY0002308 QBY0002309 QBY0002307 QBY0002351 QBY0002350 QBY0002353 QBY0002349 QBY0002355 QBY0002354 QBY0002357 QBY0002346 QBY0002344 QBY0002345 QBY0002358 QBY0002348 QBY0002356 QBY0002369 QBY0002371 QBY0002372 QBY0002370 QBY0002368 QBY0002364 QBY0002365 QBY0002363 QBY0002427 QBY0002359 QBY0002362 QBY0002360 QBY0002432 QBY0002430 QBY0002428 QBY0002431 QBY0002433 QBY0002434 QBY0002479 QBY0002480 QBY0002481 QBY0002510 QBY0002511 QBY0002512 QBY0002513 QBY0002514 QBY0002523 QBY0002530 QBY0002531 QBY0002532 QBY0002533 QBY0002563 QBY0002564 QBY0002565 QBY0002566 QBY0002571 QBY0002572 QBY0002573 QBY0002574 QBY0002575 QBY0002576 QBY0002622 QBY0002623 QBY0002624 QBY0002625 QBY0002626 QBY0002627 QBY0002629 QBY0002630 QBY0002631 QBY0002651 QBY0002652 QBY0002653 QBY0002655 QBY0002656 QBY0002657 QBY0002658 QBY0002659 QBY0002660 QBY0002661 QBY0002672 QBY0002673 QBY0002674 QBY0002675 QBY0002676 QBY0002677 QBY0002678 QBY0002679 QBY0002680 QBY0002694 QBY0002699 QBY0002700 QBY0002701 QBY0002702 QBY0002703 QBY0002709 QBY0002712 QBY0002713 QBY0002714 QBY0002715 QBY0002716 QBY0002717 QBY0002718 QBY0002731 QBY0002732 QBY0002733 QBY0002744 QBY0002745 QBY0002746 QBY0002743 QBY0002739 QBY0002737 QBY0002738 QBY0002734 QBY0002735 QBY0002736 QBY0002776 QBY0002777 QBY0002837 QBY0002779 QBY0002780 QBY0002782 QBY0002783 QBY0002784 QBY0002785 QBY0002786 QBY0002788 QBY0002789 QBY0002790 QBY0002791 QBY0002792 QBY0002793 QBY0002794 QBY0002796 QBY0002797 QBY0002810 QBY0002823 QBY0002824 QBY0002821 QBY0002822 QBY0002816 QBY0002817 QBY0002819 QBY0002814 QBY0002815 QBY0002812 QBY0002813 QBY0002833 QBY0002826 QBY0002832 QBY0002839 QBY0002840 QBY0002841 QBY0002842 QBY0002857 QBY0002858 QBY0002861 QBY0002911 QBY0002912 QBY0002913 QBY0002910 QBY0002925 QBY0003039 QBY0002939 QBY0003020 QBY0003038 QBY0003023 QBY0003019 QBY0002928 QBY0002929 QBY0002940 QBY0002941 QBY0003021 QBY0003022 QBY0003027 QBY0003024 QBY0003025 QBY0003161 QBY0003175 QBY0003183 QBY0003182 QBY0003209 QBY0003214 QBY0003217 QBY0003222 QBY0003223 QBY0003224 QBY0003226 QBY0003294 QBY0003295 QBY0003109 QBY0003134 QBY0003136 QBY0003145; (2): QBY0002288 QBY0002300 QBY0002297 QBY0002291 QBY0002282 QBY0002292 QBY0002283 QBY0002286 QBY0002376 QBY0002375 QBY0002379 QBY0002383 QBY0002381 QBY0002382 QBY0002385 QBY0002389 QBY0002393 QBY0002397 QBY0002471 QBY0002516 QBY0002517 QBY0002519 QBY0002520 QBY0002526 QBY0002527 QBY0002534 QBY0002542 QBY0002543 QBY0002552 QBY0002553 QBY0002545 QBY0002546 QBY0002547 QBY0002549 QBY0002554 QBY0002569 QBY0002570 QBY0002611 QBY0002612 QBY0002613 QBY0002615 QBY0002618 QBY0002619 QBY0002662 QBY0002663 QBY0002664 QBY0002668 QBY0002665 QBY0002669 QBY0002670 QBY0002671 QBY0002682 QBY0002683 QBY0002684 QBY0002687 QBY0002690 QBY0002704 QBY0002758 QBY0002759 QBY0002763 QBY0002764 QBY0002762 QBY0002765 QBY0002825 QBY0002845 QBY0002848 QBY0002846 QBY0002847 QBY0002862 QBY0002863 QBY0002889 QBY0002890 QBY0002885 QBY0002886 QBY0002887 QBY0002934 QBY0002914 QBY0002931 QBY0002932 QBY0003016 QBY0002930 QBY0002933 QBY0002956 QBY0002957 QBY0002958 QBY0002978 QBY0003017 QBY0003178 QBY0003179 QBY0003180 QBY0003181 QBY0003177 QBY0003186 QBY0003210 QBY0003211 QBY0003218 QBY0003219 QBY0003232 QBY0003303 QBY0003297 QBY0003314 QBY0003315 QBY0003064 QBY0003065 QBY0003066 QBY0003110 QBY0003111; (3) QBY0002361; (4) QBY0002306 QBY0002616

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

device · product 2 of 5

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

Z-1701-2019
Recall number
Z-1701-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Quantity
178 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

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

device · product 3 of 5

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.

Z-1702-2019
Recall number
Z-1702-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Quantity
10580

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

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

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

device · product 4 of 5

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.

Z-1703-2019
Recall number
Z-1703-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Quantity
7348

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

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

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

device · product 5 of 5

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator 29cm PG US Catalog Number:700106003US UPN:H787700106003US0 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.

Z-1704-2019
Recall number
Z-1704-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Quantity
1846

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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

Code information

Serial Numbers: (1) 16480626 17150699 17160704 17170705 17170706 17310766 17370790 17380795 17390797 17420814 17420817 17430823 17460844 17460847 17470850 5377356 (2) 17200721 17210722 17220730 17220731 17220732 17250743 17270749 17300765 17320771 17380794 17400805 17420816 17440830 17470849 5346596 5355835 5385267 5392055 5392056 5416590 5426407 5446902

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