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.
Recall
- Recall Number
- Z-0626-2019
- Event Number
- 81595
- Firm
- Covidien LLC
- FEI Number
- 1219930
- Product Code
- NEY
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 15, 2018
- Address
- 60 Middletown Ave, North Haven, CT, 06473-3908
Description
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.
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.
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.
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