Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
- Company
- Covidien Llc
- Recall Initiated
- August 7, 2017
- Recall Number
- Z-0560-2018
- Firm Location
- North Haven, CT
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
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
Root Cause
Device Design
Action Taken
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.