FDA Recalls Covidien Emprint Percutaneous Antenna Due to Tip Disengagement
FDA is recalling specific lots of the Covidien Emprint Long Percutaneous Antenna because the ceramic trocar tip may disengage from the needle shaft, potentially remaining in the patient.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 involves a structural defect where a component may remain in the patient, posing a significant injury risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific lots of the Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2. This medical device is intended for percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including the ablation of nonresectable liver tumors. The recall is limited to the specific lot numbers listed in the agency's official notice.
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 distribution of the affected units was nationwide in the United States.
Healthcare providers and patients who have used or are scheduled to use this device should contact their healthcare provider or the manufacturer for further instructions. The FDA advises that the device should not be used until further notice.
The recalled product
- Product
- Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 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
- Category
- Medical Device — Ablation Device
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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