FDAClass IIDecember 26, 2018

Covidien Emprint Long Percutaneous Antenna with recall

Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and…

Why was Covidien Emprint Long Percutaneous Antenna with recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN Number - 10884521706606 Lot Numbers- S7HG007KX S7HG008KX S7HG009KX S7HG032LX S7HG033LX S7HG034LX S7JG008LX S7JG009X S7JG012X S7KG012LX S7KG038QX S7LG009X S7MG010LX S7MG019X S8BG004X S8BG005X S8CG002X S8DG001X S8DG026X S8EG004X

Product
Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and…
Recalling firm
Covidien LLC
Distribution
US Nationwide
Recall date
December 26, 2018
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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