FDA Enforcement
Class II
Ongoing
Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
Recall: Z-0625-2019
·
Reported December 26, 2018
Enforcement
- Recall Number
- Z-0625-2019
- Event ID
- 81595
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Covidien LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 26, 2018
- Initiation Date
- November 15, 2018
- Classification Date
- December 18, 2018
- Address
- 60 Middletown Ave, North Haven, CT, 06473-3908, United States
Description
Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.
Reason
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.
Code Info
GTIN Number - 10884521706606 Lot Numbers- S7HG007KX S7HG008KX S7HG009KX S7HG032LX S7HG033LX S7HG034LX S7JG008LX S7JG009X S7JG012X S7KG012LX S7KG038QX S7LG009X S7MG010LX S7MG019X S8BG004X S8BG005X S8CG002X S8DG001X S8DG026X S8EG004X
Distribution
US Nationwide