FDA-Device2018-12-26Class II
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.
Covidien LLC
Hazard
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.
Sold states
US Nationwide
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0627-2019Don't want to check this manually?
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