# FDA recall Z-1703-2019

> **Angiodynamics Inc. (Navilyst Medical Inc.)** · Class II · device recall initiated 2019-04-17.

## Product

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.

## 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

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

## Key facts

- **Recall number:** Z-1703-2019
- **Recalling firm:** Angiodynamics Inc. (Navilyst Medical Inc.)
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-17
- **Report date:** 2019-06-12
- **Termination date:** 2020-06-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Glens Falls, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1703-2019

## Citation

> AI Analytics. FDA recall Z-1703-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1703-2019. Source: US FDA. Licensed CC0.

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