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Emprint recallZ-0627-2019 · Covidien LLC · initiated Nov 15, 2018

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Covidien LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0627-2019
Status
Open, Classified
Initiated by the company
Nov 15, 2018
Recalling firm
Covidien LLC
Product code
NEY
FDA submissions
K163105
Distribution
US Nationwide

Product description

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K163105 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 81595).

Sources and updates

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