Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling the Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), model CA30L2, distributed nationwide including Puerto Rico, Canada, and China. The ceramic trocar tip of this ablation antenna can disengage from the needle shaft after the procedure is completed, which may result in the tip remaining inside the patient's body. The affected product has UDI 10884521706606 and includes lot codes S6MG007PX, S6MG010PX, S6MG016PX, S7AG002PX, S7BG005X, S7BG009X, S7DG004X, and S7FG006X.
The source does not specify a remedy for consumers who have this product.
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: Nationwide including PR, Canada, China Quantity: N/A Lot/code info: UDI 10884521706606, Lot codes: S6MG007PX,S6MG010PX,S6MG016PX,S7AG002PX,S7BG005X,S7BG009X,S7DG004X,S7FG006X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.