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
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
Bridge Occlusion Balloon
Lot or serial number
Not applicable.
Model or catalog number
590-001
Companies
- Manufacturer
-
Spectranetics Corporation
9965 FEDERAL DRIVE
COLORADO SPRINGS
80921
Colorado
UNITED STATES