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UNIFY, FORTIFY AND QUADRA (2016-10-07)
- Starting date:
- October 7, 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-60698
Affected Products
A. UNIFY
B. FORTIFY ST VR
C. FORTIFY ST DR
D. FORTIFY ASSURA DR
E. FORTIFY ASSURA VR
F. QUADRA ASSURA MP
Reason
St. Jude Medical has identified a risk of premature battery depletion associated with certain St. Jude medical implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices manufactured before May 23, 2015. There is evidence of lithium material in the form of "clusters" in the battery. Some devices exhibited visible clusters bridging the cathode and anode causing shorting. Lithium cluster formation is a known phenomenon with this type of battery.
Affected products
A. UNIFY
Lot or serial number
Not Applicable
Model or catalog number
CD3231-40
CD3235-40
CD3235-40Q
Companies
- Manufacturer
-
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES
B. FORTIFY ST VR
Lot or serial number
Not Applicable
Model or catalog number
CD1235-40
CD1235-40Q
Companies
- Manufacturer
-
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES
C. FORTIFY ST DR
Lot or serial number
Not Applicable
Model or catalog number
CD2235-40
CD2235-40Q
Companies
- Manufacturer
-
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES
D. FORTIFY ASSURA DR
Lot or serial number
Not Applicable
Model or catalog number
CD2259-40
CD2259-40Q
CD2359-40C
CD2359-40QC
Companies
- Manufacturer
-
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES
E. FORTIFY ASSURA VR
Lot or serial number
Not Applicable
Model or catalog number
CD1259-40
CD1259-40Q
CD1359-40C
CD1359-40QC
Companies
- Manufacturer
-
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES
F. QUADRA ASSURA MP
Lot or serial number
Not Applicable
Companies
- Manufacturer
-
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES