Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling the Emprint Percutaneous Antenna with Thermosphere Technology, 30cm model (Material CA30L1) because the ceramic trocar tip can disengage from the needle shaft after the ablation procedure is completed, potentially leaving the tip inside the patient's body. The affected product was distributed nationwide, including Puerto Rico, Canada, and China, with specific lot codes identified by UDI 10884521189553.
The recall notice does not specify a remedy or recommended action for affected consumers.
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 10884521189553, Lot codes: S5LG004PX,S6AG001X,S6BG002X,S6BG005X,S6BG016PX,S6CG003X,S6CG005X,S6CG017X,S6DG004X,S6EG001X,S6FG001X,S6FG006X,S6FG010X,S6KG002X,S6KG006PRX,S6KG006PX,S6LG004X,S6MG002X,S7CG001PCX,S7CG011PCX,S7CG015CX,S7EG001X,S7EG003X,S7FG011PX
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.