FDA-Device2018-02-14Class II
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
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
Nationwide including PR, Canada, China
Affected count
N/A
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0556-2018Don't want to check this manually?
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