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.
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling the Emprint Long Percutaneous Antenna with Thermosphere Technology (Material CA30L2), a medical device used for ablation procedures. The company received reports that the ceramic trocar tip of this antenna can disengage from the needle shaft after ablation is completed, which may result in the tip remaining inside the patient's body. The affected product was distributed nationwide and includes multiple lot numbers, which can be identified by GTIN number 10884521706606.
The recall affects specific lot numbers including S7HG007KX, S7HG008KX, S7HG009KX, S7HG032LX, S7HG033LX, S7HG034LX, S7JG008LX, S7JG009X, S7JG012X, S7KG012LX, S7KG038QX, S7LG009X, S7MG010LX, S7MG019X, S8BG004X, S8BG005X, S8CG002X, S8DG001X, S8DG026X, S8EG004X, and S8EG004X. The source document does not specify what remedy or action affected consumers should take.
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 - 10884521706606 Lot Numbers- S7HG007KX S7HG008KX S7HG009KX S7HG032LX S7HG033LX S7HG034LX S7JG008LX S7JG009X S7JG012X S7KG012LX S7KG038QX S7LG009X S7MG010LX S7MG019X S8BG004X S8BG005X S8CG002X S8DG001X S8DG026X S8EG004X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.