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

• Reason
• Affected products

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