FDA (Devices) recall action 79075
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
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.
The agency’s own wording, quoted from the enforcement report.
FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
FDA is recalling specific lots of the Covidien Emprint Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
FDA is recalling the Covidien Emprint Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
FDA Class II recall of Covidien Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft and remain in the patient.
FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
FDA is recalling Emprint Percutaneous Antennas because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.