Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 12, 2019
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.
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
Angiodynamics Inc. (Navilyst Medical Inc.) recalled AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm … - a moderate-severity action.
AngioDynamics Solero Microwave Tissue Ablation (MTA) System: (1)Solero Applicator 19cm … was recalled by Angiodynamics Inc. (Navilyst Medical Inc.) in June 12, 2019. Reason: Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the ris…. Check the official notice for the remedy. Verify recall #Z-1703-2019 with the FDA Devices before acting.
The recall
Angiodynamics Inc. (Navilyst Medical Inc.) issued this moderate-severity FDA Devices recall-Updated Warning Statements in the Operator's Manual/Directions for Use and Software Updates to reduce the ris….
- Moderate
- severity level
- 7K units
- affected scope
- Class II
- classification
- June 12, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1703-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1703-2019) was formally reported on June 12, 2019, with the manufacturer initiating the action on April 17, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Angiodynamics Inc. (Navilyst Medical Inc.) is listed as the recalling firm, operating out of Glens Falls, NY. Federal records list the affected scope as 7348.
The documented reason for this recall is: 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 data in the federal record shows the product reached: 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 …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
7348
Related Recalls
6
6 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1703-2019 |
| Date reported | June 12, 2019 |
| Date initiated | April 17, 2019 |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Firm location | Glens Falls, NY |
| Affected scope | 7348 |
| 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1703-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Angiodynamics Inc. (Navilyst Medical Inc.). Units affected: 7348.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 12, 2019. Severity: Moderate. Recall number: Z-1703-2019.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1703-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 12, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.