Z-1704-2019Class II

AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog...

Name: Z-1704-2019 AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog...
Creator: Angiodynamics Inc. (Navilyst Medical Inc.)
Published: 2019-04-17
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2019-04-17 / Terminated / root cause: design

FDA source

Angiodynamics Inc. (Navilyst Medical Inc.) began a recall of AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 29cm PG Catalog Number:700106003 UPN: H7877001060030 (2)Solero Applicator... on 2019-04-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1704-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-17
Posted: 2019-05-31
Terminated: 2020-06-09
Recalling firm: Boston Scientific Corporation
Product: 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.
Product code: NEY System, Ablation, Microwave And Accessories
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
Root cause tag: design
FDA root cause: Device Design
Action: AngioDynamics issued on April 17, 2019 AngioDynamics initiated a Field Correction by issuing notifications via Federal Express. Consignees are instructed to replace the existing Solero Generator User Manual with the revised version provided with the Notification. Once the replacement has been made, the consignees are instructed to complete and return the Reply Verification Tracking Form, provided in the notification. AngioDynamics will also install a software update to help reduce the incidence of Error 0001 which can occur during initial start-up. This improvement will be implemented on the next servicing of the Solero Microwave Tissue Ablation System Generator. Questions regarding the corrective action as stated above, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time).
Quantity in commerce: 1846
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1704-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1700-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-05-31
Z-1701-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-05-31
Z-1702-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-05-31
Z-1703-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-05-31
Z-1704-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-05-31

Product code NEY

K162449Class IISolero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)AngioDynamics, Inc. / cleared 2017-05-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)