StraightShot Microdebrider System XPS Blades (2018-05-30)

Starting date:

May 30, 2018

Posting date:

June 29, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-67122

• Reason
• Affected products

Affected products

StraightShot Microdebrider System XPS Blades

Reason

This voluntary recall is being conducted due to potential for irrigation port blockage. The irrigation pin used to manufacture (molding) the hub outer tube was incorrectly placed in the mold which resulted in blockage of the irrigation lumen. Medtronic Puerto Rico Operations Company (MPROC) presented an issue in which the 66d1204 hub outer tube w/barb 3.5mm molded hub manufactured at Medtronic ENT Jacksonville had one cavity with a blocked irrigation port.

Affected products