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Use caution Medical device recall · FDA · Published September 29, 2021

Covidien Emprint A: Temperature Monitoring Error Risks Tissue Damage

Covidien recalls Emprint Ablation Catheter with Thermosphere Technology (CFN CA108L1) due to temperature monitoring error that could cause overheating and tissue damage if primary cooling fails.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0210-2022Medical deviceCovidien ›
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Contact the company

Recalling firmCovidien Llc15 Hampshire St · Mansfield, MA 02048-1113
✎ GovInfoNow plain-language explainer

Covidien is recalling its Emprint Ablation Catheter with Thermosphere Technology (model CFN CA108L1) because a temperature monitoring error could cause the device to overheat if the primary cooling system fails. This risk may lead to tissue burns, allergic reactions, or delayed treatment. Read more at govinfonow.com/recall/61741-covidien-emprint-a-temperature-monitoring-error-risks-tissue-damage.

Source Summary by GovInfoNow · govinfonow.com/recall/61741-covidien-emprint-a-temperature-monitoring-error-risks-tissue-damage · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0210-2022

Cite this page

“Covidien Emprint A: Temperature Monitoring Error Risks Tissue Damage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61741-covidien-emprint-a-temperature-monitoring-error-risks-tissue-damage. Based on FDA recall #Z-0210-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0210-2022%22&limit=1).

The FDA announced on 2021-09-29 that Covidien LLC voluntarily recalled the Emprint Ablation Catheter with Thermosphere Technology due to a temperature monitoring circuitry error. This defect could cause the applicator tip to overheat, potentially resulting in heat damage and allergic or toxic reactions.

How to tell if you have it

  • Brand: Covidien
  • Product: Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation
  • CFN: CA108L1
  • Lot code: 516840

The hazard

The firm identified an error in the device temperature monitoring circuitry designed to interrupt energy delivery during a primary cooling system failure. Use of an affected device with such a failure could lead to applicator tip overheating and associated heat damage, which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.

Context

GovInfoNow's records show Covidien LLC has 52 other recalls on record since 2017-08-07. Other recent recalls include the Covidien EndoFLIP System recall on 2026-05-13 and the Covidien Mon-a-Therm Stethoscope Recall on 2026-04-23.

How to tell if you have this one

Check for the model number CFN CA108L1 on the device. The recall applies to the specific lot number 516840.

  • Brand
    Covidien
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Look for the model number CFN CA108L1 on the device label.

  2. Contact Manufacturer

    Reach out to Covidien LLC for guidance on next steps if you have the recalled device.

How this recall unfolded

Recall timeline

FDA terminated this recall 3.4 years after the firm started it.

1. Firm started the recall: Sep 29, 202112. FDA classified it Class II: Nov 5, 202123. Published in FDA’s Enforcement Report: Nov 17, 202134. FDA terminated the recall: Feb 13, 2025420212025
  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-0210-2022 (September 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0210-2022 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.