Sensor Guidewire (2020-03-09)

Starting date:

March 9, 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-72775

Last updated: 2020-04-17

• Reason
• Affected products

Affected Products

Sensor Guidewire

Reason

Boston Scientific is initiating a removal of specific lots/batches of Sensor Nitinol Guidewire with hydrophilic tip.  BSC has noted an increase in the rate of complaints reported for affected devices for difficulty or inability to track over the guidewire.

Affected products