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SynCardia Companion 2 Driver System (2015-06-26)
- Starting date:
- June 26, 2015
- Posting date:
- August 11, 2015
- 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-54568
Affected Products
A. SynCardia Companion 2 Driver System
Reason
Notification to surgeons of a possible safety risk for patients requiring pre-implant circulatory rescue intervention. Preliminary data analysis from INTERMACS companion post approval study suggests there may be a higher mortality rate when patient supported by the C2 Driver System.
Affected products
A. SynCardia Companion 2 Driver System
Lot or serial number
N/A
Model or catalog number
397002-001
Companies
- Manufacturer
-
SYNCARDIA SYSTEMS, INC
1992 EAST SILVER LAKE ROAD,
Tucson
Arizona
UNITED STATES