Z-0210-2022Class II

Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

Name: Z-0210-2022 Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Creator: Covidien Llc
Published: 2021-09-29
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-09-29 / Terminated / root cause: manufacturing process

FDA source

Covidien Llc began a recall of Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1 on 2021-09-29. FDA classified it as Class II and gives the reason as "The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0210-2022
Classification: Class II
Status: Terminated
Initiated: 2021-09-29
Posted: 2021-11-05
Terminated: 2025-02-13
Recalling firm: Medtronic, Inc.
Product: Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Product code: NEY System, Ablation, Microwave And Accessories
Reason for recall: The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Beginning September 29, 2021, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were asked to immediately quarantine and discontinue use of the affected products. Customers should return affected product to the firm. If product has been further distributed, please forward the recall information. Customers should complete and return the accompanying response form even if they do not have product on hand.
Quantity in commerce: 14 units
Distribution: No domestic distribution. Foreign distribution to Hong Kong and UK.
Product codes and lots: Lot 516840

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0210-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0210-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-17	2021-11-05

Product code NEY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)