—#169031

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.

FDA product code: NEY — System, Ablation, Microwave And Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K163105
Affected lot / code info: 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

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2018-11-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169031. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.