Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling Emprint Percutaneous Antenna with Thermosphere Technology 15cm ablation devices because the ceramic trocar tip can separate from the needle shaft after the ablation procedure is completed. If this occurs, the tip may remain inside the patient's body. The affected product has UDI 10884521189539 and includes numerous lot codes beginning with S5LG, S5MG, S6, and S7. The recalled devices were distributed nationwide, including Puerto Rico, Canada, and China.
The recall notice does not specify what consumers or healthcare providers should do in response to this recall.
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 10884521189539, Lots S5LG002PX,S5MG004PX,S5MG009PX,S5MG010PX,S5MG013PX,S5MG017PX,S5MG019PX,S6AG002X,S6AG003X,S6AG006X,S6AG009X,S6AG010X,S6BG001X,S6BG006X,S6BG012X,S6BG013X,S6BG014PX,S6CG001X,S6CG004X,S6CG006X,S6CG007X,S6CG009X,S6CG013X,S6CG018X,S6CG019X,S6DG001X,S6DG003X,S6DG006X,S6DG008X,S6DG009X,S6EG002X,S6EG003X,S6EG005X,S6EG007X,S6EG010X,S6FG002X,S6FG003X,S6FG004X,S6FG009X,S6GG004X,S6GG005X,S6GG006X,S6GG008X,S6GG009X,S6GG011X,S6GG012X,S6GG015X,S6HG002X,S6HG010X,S6HG011X,S6HG013X,S6KG001X,S6KG004PRX,S6KG004PX,S6KG007X,S6KG008X,S6KG010X,S6KG014X,S6KG015X,S6KG017X,S6LG001X,S6LG003X,S6LG005X,S6LG006X,S6LG008X,S6LG009X,S6LG010X,S6MG001X,S6MG004X,S6MG017X,S7AG004X,S7BG002X,S7BG011PCX,S7CG009PCX,S7CG012PCX,S7CG016X,S7DG001X,S7DG006X,S7EG002X,S7EG004X,S7EG005X,S7FG009PX,S7GG001X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.