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Lower risk Medical device recall · FDA · Published April 22, 2021

St Jude Medical NeuroTherm NT2000iX RF Generator Recall: Potential Capacitor Failure

St Jude Medical recalls NeuroTherm NT2000iX Radiofrequency Generators with serial numbers listed. Potential capacitor failure may cause output issues or charring/smoky odor. Consumers should check if their device has listed serial numbers.

🇺🇸 FDA recall #Z-1549-2021Medical deviceSt Jude Medical ›
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Contact the company

Recalling firmAbbott Laboratories Inc. (St Jude Medical)1 Saint Jude Medical Dr · Saint Paul, MN 55117-1789
✎ GovInfoNow plain-language explainer

St Jude Medical is recalling NeuroTherm NT2000iX Radiofrequency Generators due to potential capacitor failure that could cause output issues or charring/smoky odor. This may affect medical devices used for nerve stimulation treatments. Read more at govinfonow.com/recall/62743-st-jude-medical-neurotherm-nt2000ix-rf-generator-recall-potential-capacitor.

Source Summary by GovInfoNow · govinfonow.com/recall/62743-st-jude-medical-neurotherm-nt2000ix-rf-generator-recall-potential-capacitor · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1549-2021

Cite this page

“St Jude Medical NeuroTherm NT2000iX RF Generator Recall: Potential Capacitor Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62743-st-jude-medical-neurotherm-nt2000ix-rf-generator-recall-potential-capacitor. Based on FDA recall #Z-1549-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1549-2021%22&limit=1).

The FDA announced on April 22, 2021, that Abbott Laboratories Inc. (St Jude Medical) is recalling the NeuroTherm NT2000iX Radiofrequency Generator due to a potential capacitor failure. The agency issued recall number Z-1549-2021 for the Class II device.

How to tell if you have it

  • Brand: St Jude Medical
  • Product: NeuroTherm NT2000iX Radiofrequency (RF) Generator
  • Model Number: RFG-NT-2000
  • UDI: 05415067022417
  • Units affected: 318

The hazard

The hazard is a potential capacitor failure that typically manifests as an inability to provide output on one or more channels. In some instances, users reported a charring or smoky odor or emission.

Context

GovInfoNow's records show Abbott Laboratories Inc. (St Jude Medical) has two other recalls on record since April 5, 2019. On May 5, 2021, the company recalled the St Jude Medical WorkMate Claris System v1.2 Upgrade Kit due to a software error that may cause screen blackout. Other recent recalls of similar products include the Gentherm Medical Innercool Coolblue Console Overheating Recall (July 13, 2026) and the Philips Allura Xper FD10F Medical System Recall (Dec. 15, 2025).

How to tell if you have this one

Check if your NeuroTherm NT2000iX Radiofrequency Generator has a serial number listed in the provided list (e.g., 18675078, 18709738, etc.).

  • Brand
    St Jude Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Serial Number

    Compare your device's serial number with the list provided in the recall to determine if it is affected.

How this recall unfolded

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Apr 22, 202112. FDA classified it Class II: May 10, 202123. Published in FDA’s Enforcement Report: May 19, 202134. FDA terminated the recall: Feb 2, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1549-2021 (April 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1549-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA