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.
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling the Emprint Standard Percutaneous Antenna with Thermosphere Technology (model CA20L2), a medical device used for ablation of soft tissue during percutaneous, laparoscopic, and intraoperative procedures. The company received reports that the ceramic trocar tip of the antenna can separate from the needle shaft after the ablation procedure is completed, potentially leaving the tip inside the patient's body.
The recalled device was distributed nationwide in the United States across multiple lot numbers. The recall document does not specify a remedy or instructions for consumers regarding what steps should be taken.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide Lot/code info: GTIN Number - 10884521706590 Lot Numbers- S7HG001PX S7HG004KX S7HG010KX S7HG011KX S7HG012KX S7HG030LX S7HG031LX S7HG035LX S7HG039LX S7HG042LX S7HG043X S7JG006X S7JG010X S7JG013X S7JG014X S7KG008LX S7KG009LX S7KG010LX S7KG041X S7KG043X S7LG003X S7LG004X S7MG003X S7MG004LX S7MG017PX S7MG029X S8BG001X S8BG002X S8BG006X S8CG001X S8CG008LX S8CG009X S8CG018X S8CG023X S8DG019LX S8DG020LX S8DG021LX S8DG022LX S8DG023X S8DG025X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.