Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling the Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), a medical device used for ablation procedures. The recall was initiated because the ceramic trocar tip of the antenna can disengage from the needle shaft after the ablation procedure, potentially leaving the tip inside the patient's body. The affected product has a UDI of 10884521706583 and includes multiple lot codes ranging from S6MG005PX through S7FG007X. The device was distributed nationwide including Puerto Rico, Canada, and China.
According to the recall record provided, no remedy is specified for consumers who may have received or used 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 10884521706583, Lot codes: S6MG005PX,S6MG008PX,S6MG012PX,S6MG019PX,S7AG001PX,S7AG006X,S7AG010X,S7AG013X,S7BG001X,S7BG003X,S7BG007X,S7BG013X,S7CG002X,S7CG005X,S7CG007X,S7CG013X,S7EG009X,S7FG003X,S7FG004X,S7FG007X
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.