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Temporary Myocardial Bipolar Heartwire
- Starting date:
- July 25, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15888
Recalled Products
A. Temporary Myocardial Bipolar Heartwire
Reason
Spacing between zig-zag wire and insulation is too long (10mm instead of 2mm). The defect affects the proper placement of zig-zag into the heart wall and subsequent electrical contact might be compromised.
Affected products
A. Temporary Myocardial Bipolar Heartwire
Lot or serial number
C1-07056
Model or catalog number
TME 64-S
Companies
- Manufacturer
- Oscor Inc.