Bridge Occlusion Balloon (2020-03-30)

Starting date:

March 30, 2020

Posting date:

April 17, 2020

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-72815

Last updated: 2020-04-17

• Reason
• Affected products

Affected Products

Bridge Occlusion Balloon

Reason

There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations (mean 176±118Min).   The formation of thrombus by foreign objects placed in the vasculature is a known phenomenon and would be expected to occur with any balloon left dwelling in a vein for an extended period of time.  While this is common knowledge for physicians that routinely do catheter based work (i.e., IRS, ICS), we have come to realize this is not common knowledge for the physicians (i.e., electrophysiologists) performing lead extraction cases and using these balloons as rescue devices.

Affected products