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.
- Company
- Covidien Llc
- Recall Initiated
- November 15, 2018
- Recall Number
- Z-0626-2019
- Firm Location
- North Haven, CT
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.
Distribution
US Nationwide
Lot / Code Info
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
Root Cause
Nonconforming Material/Component
Action Taken
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.