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Emprint Percutaneous Antenna With Thermoshere Technology
- Starting date:
- August 8, 2017
- Posting date:
- September 5, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Hospitals, Healthcare Professionals
- Identification number:
- RA-64428
Reason
This voluntary recall is being conducted following six customer reports of the Ceramic Trocar Tip of the Emprint Ablation Antenna disengaging from the needle shaft post-ablation. Tip disengagement can result in the ceramic trocar tip remaining in the patient presenting a risk of latent migration and potential damage to adjacent tissue.
Affected products
Emprint Percutaneous Antenna With Thermoshere Technology
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- CA15L1
- CA15L2
- CA20L1
- CA20L2
- CA30L1
- CA30L2
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES