Z-0626-2019Class II

Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in...

Name: Z-0626-2019 Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 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 Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 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-0626-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-11-15
Posted: 2018-12-18
Recalling firm: Medtronic, Inc.
Product: Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 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 - 10884521706583 Lot Numbers- S7HG002X S7HG003X S7HG005KX S7HG006KX S7HG022LX S7HG023LX S7HG024LX S7HG025LX S7HG029LX S7HG040X S7HG041X S7HG045X S7HG049X S7JG007X S7JG011X S7JG033LX S7JG034X S7JG035X S7JG041LX S7JG042LX S7JG043LX S7JG044LX S7JG045LX S7JG046LX S7JG047LX S7KG023LX S7KG029X S7KG033X S7KG039X S7KG040X S7KG042X S7LG001X S7LG002X S7LG006X S7LG011X S7LG012X S7MG008LX S7MG009LX S7MG011X S7MG012X S7MG014X S7MG018X S7MG020X S7MG021X S7MG022PX S7MG023PX S7MG024X S7MG025X S7MG026X S8AG001X S8AG002X S8AG011X S8AG013X S8CG004X S8CG010X S8CG017X S8CG019PX S8CG022PX S8CG025X S8DG014LX S8DG015LX S8DG016LX S8DG017LX S8DG018LX S8DG024X S8DG027X S8EG005X S8EG009X S8EG010X S8EG011X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0626-2019
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)