FDA Recalls Covidien Emprint Percutaneous Ablation Antenna Due to Tip Disengagement
FDA is recalling the Covidien Emprint Standard Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a foreign object remaining in the patient, which constitutes a significant injury risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling the Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, model CA20L2. This medical device is intended for percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including the ablation of nonresectable liver tumors.
The recall was initiated after the firm received consumer reports that the ceramic trocar tip of the antenna disengaged from the needle shaft after the ablation procedure. This defect can result in the tip remaining inside the patient.
The affected product is distributed nationwide in the United States. The recall covers specific lot numbers, including S7HG001PX, S7HG004KX, and S7HG010KX, among others. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Covidien LLC
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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