Temporary Bipolar Pacing Leads (2018-09-09)
- Starting date:
- September 9, 2018
- Posting date:
- October 26, 2018
- 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-68070
Affected products
Temporary Bipolar Pacing Leads
Reason
The connector plastic cap housing covering the proximal end of the TB unshrouded models may slide forward over the pin during insertion into the pacemaker generator exposing the wire connection on the 2mm pin. In some instances this may cause the wire to be more susceptible to loss of connectivity or breakage during flexing of the cables.
Affected products
Temporary Bipolar Pacing Leads
Lot or serial number
All lots.
Model or catalog number
- TB 4 F U
- TB 5 F U
- TB 6 F U
Companies
- Manufacturer
-
Oscor Inc.
3816 De Soto Boulevard
Palm Harbor
34683
Florida
UNITED STATES