Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2
Check against the official notice below — it lists the full affected range.
Covidien LLC has recalled the Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), due to reports that the ceramic trocar tip can disengage from the needle shaft after the ablation procedure is performed. If the tip disengages, it may remain inside the patient's body. The affected product has UDI 10884521706590 and includes multiple lot codes: S6MG006PX, S6MG009PX, S6MG013PX, S6MG020PX, S7AG011X, S7AG012X, S7BG008X, S7CG003X, S7DG003X, S7DG009X, S7FG001X, S7FG002X, S7FG005X, and S7FG008X. The recalled product was distributed nationwide, including Puerto Rico, Canada, and China.
The recall record does not specify a remedy or instructions for what consumers should do regarding this recalled 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 10884521706590, Lot codes: S6MG006PX,S6MG009PX,S6MG013PX,S6MG020PX,S7AG011X,S7AG012X,S7BG008X,S7CG003X,S7DG003X,S7DG009X,S7FG001X,S7FG002X,S7FG005X,S7FG008X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.