Z-0627-2019Class II

Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in...

Name: Z-0627-2019 Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in...
Creator: Covidien LLC
Published: 2018-11-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2018-11-15 / Open, Classified / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative... on 2018-11-15. FDA classified it as Class II and gives the reason as "The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient". 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-0627-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-11-15
Posted: 2018-12-18
Recalling firm: Medtronic, Inc.
Product: Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
Product code: NEY System, Ablation, Microwave And Accessories
Reason for recall: The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On November 15, 2018 Medtronic issued UPDATED URGENT MEDICAL DEVICE RECALL notices to customers. Customers are advised to take the following actions: 1. Please immediately quarantine and discontinue use of the affected products. 2. Return affected product as indicated. 3. If you have distributed the products, please promptly forward the information from the letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Technical Support at (800) 448-3644, Option 3, Option 8.
Distribution: US Nationwide
Product codes and lots: GTIN Number - 10884521706590 Lot Numbers- S7HG001PX S7HG004KX S7HG010KX S7HG011KX S7HG012KX S7HG030LX S7HG031LX S7HG035LX S7HG039LX S7HG042LX S7HG043X S7JG006X S7JG010X S7JG013X S7JG014X S7KG008LX S7KG009LX S7KG010LX S7KG041X S7KG043X S7LG003X S7LG004X S7MG003X S7MG004LX S7MG017PX S7MG029X S8BG001X S8BG002X S8BG006X S8CG001X S8CG008LX S8CG009X S8CG018X S8CG023X S8DG019LX S8DG020LX S8DG021LX S8DG022LX S8DG023X S8DG025X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0627-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0625-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-26	2018-12-18
Z-0626-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-26	2018-12-18
Z-0627-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-12-26	2018-12-18

Product code NEY

K163105Class IIEmprint Ablation SystemCovidien, LLC / cleared 2016-12-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)