Z-0561-2018Class II

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2

Name: Z-0561-2018 Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
Creator: Covidien LLC
Published: 2017-08-07
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-08-07 / Open, Classified / root cause: design

FDA source

Covidien LLC began a recall of Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2 on 2017-08-07. 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 design.

Recall record

Recall number: Z-0561-2018
Classification: Class II
Status: Open, Classified
Initiated: 2017-08-07
Posted: 2018-02-09
Recalling firm: Medtronic, Inc.
Product: Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
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: design
FDA root cause: Device Design
Action: All consignees were notified via Federal Express or certified mail on August 7, 2017, and the letter informs customers of the possible trocar tip disengagement and the actions they should take. Customers are requested to segregate and return affected product and acknowledge receipt and understanding of the Urgent Medical Device Recall Notice.
Distribution: Nationwide including PR, Canada, China
Product codes and lots: UDI 10884521706606, Lot codes: S6MG007PX,S6MG010PX,S6MG016PX,S7AG002PX,S7BG005X,S7BG009X,S7DG004X,S7FG006X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0561-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0556-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-02-14	2018-02-08
Z-0557-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-02-14	2018-02-08
Z-0558-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-02-14	2018-02-08
Z-0559-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-02-14	2018-02-08
Z-0560-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-02-14	2018-02-08
Z-0561-2018	Class II	Ongoing	Voluntary: Firm initiated	2018-02-14	2018-02-08

Product code NEY

K133821Class IIEmprint Ablation SystemCovidien, LLC / cleared 2014-04-28

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)