THERASPHERE ADMINISTRATION SET (2021-07-23)

Starting date:

July 23, 2021

Posting date:

August 6, 2021

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-76171

Last updated: 2021-08-06

• Reason
• Affected products

Affected Products

THERASPHERE ADMINISTRATION SET

Reason

Boston Scientific is initiating a Product Advisory for specific lots of TheraSphereTM Administration Sets to reinforce the existing administration set assembly instructions within the instructions for use (IFU), which state to firmly connect the outlet luer to the patient catheter. This Product Advisory will also inform users of the potential for leaks at this connection.

Affected products