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 Recall Z-0627-2019 · Posted None
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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.
Firm Action
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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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