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EMPRINT PERCUTANEOUS ANTENNA WITH THERMOSPHERE TECHNOLOGY (2016-02-24)
- Starting date:
- February 24, 2016
- Posting date:
- March 10, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57470
Affected Products
- EMPRINT PERCUTANEOUS ANTENNA WITH THERMOSPHERE TECHNOLOGY
Reason
This recall is being conducted following customer reports of the Emprint Ablation Generator shutting down due high temperature measurements in the Emprint Percutaneous Antenna. If the generator shuts down due to elevated temperature readings at the antenna must be replaced and the ability to tract ablate is limited.
Affected products
-
EMPRINT PERCUTANEOUS ANTENNA WITH THERMOSPHERE TECHNOLOGY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- CA15L1
- CA20L1
- CA30L1
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES