—#161306

Product

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2

FDA product code: NEY — System, Ablation, Microwave And Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K133821
Affected 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

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

All consignees were notified via Federal Express or certified mail on August 7, 2017, and the letter informs customers of the possible trocar tip disengagement and the actions they should take. Customers are requested to segregate and return affected product and acknowledge receipt and understanding of the Urgent Medical Device Recall Notice.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: Nationwide including PR, Canada, China

Timeline

Recall initiated: 2017-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161306. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.