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OPTISURE DEFIBRILLATION LEAD (ACTIVE FIXATION) (2015-11-02)
- Starting date:
- November 2, 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-55864
Affected Products
OPTISURE DEFIBRILLATION LEAD (ACTIVE FIXATION)
Reason
During the manufacturing process of a limited number of Optisure leads, a trim technique used to remove excess medical adhesive around the superior vena cava (SVC) shock coil may have introduced damage to the lead's insulation.
Affected products
OPTISURE DEFIBRILLATION LEAD (ACTIVE FIXATION)
Lot or serial number
S/N BRG010437
S/N BRL010010
Model or catalog number
LDA220Q
LDA230Q
Companies
- Manufacturer
-
St. Jude Medical, Cardiac Rhythm Management Division
15900 VALLEY VIEW COURT
Sylmar
91342
California
UNITED STATES