Z-0955-2023Class II

COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

Name: Z-0955-2023 COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Creator: Covidien, LLC
Published: 2022-11-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-11-23 / Open, Classified / root cause: manufacturing process

FDA source

Covidien, LLC began a recall of COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1 on 2022-11-23. FDA classified it as Class II and gives the reason as "The product is labeled with the incorrect expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0955-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-23
Posted: 2023-01-12
Recalling firm: Medtronic, Inc.
Product: COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
Product code: NEY System, Ablation, Microwave And Accessories
Reason for recall: The product is labeled with the incorrect expiration date.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On about 11/23/2022, the single customer was notified with an "URGENT: MEDICAL DEVICE RECALL" letter via visit. The letter instructed the consignee to immediately identify, segregate, and quarantine affected products within your inventory, pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred, and to contact Medtronic to return affected product. Additionally. the consignee was instructed to complete and return the customer confirmation form even if you do not have any affected units. Return the form via email to [email protected] within 30 days of receipt. Contact us at 1-800-255-6774 to receive a return material authorization (RMA) and coordinate inventory replacement/credit. Return unopened affected units to: Medtronic Attention: [Insert RGA #], 4340 Swinnea Rd, Bldg A Memphis, TN 38118. If you have any questions regarding this communication, please contact your Medtronic Representative or Medtronic Customer Service at 800-962-9888.
Quantity in commerce: 21 units
Distribution: Foreign Distribution: Hong Kong
Product codes and lots: UDI/DI (GTIN): 10884521825765, Lot Number: 520200

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0955-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0955-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-01-18	2023-01-12

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)