Health product recall

Spaceoar System

Last updated

Summary

Product
Spaceoar System
Issue
Medical devices - Revised instructions for use
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or Serial Number Model or catalog number
Spaceoar System All lots. SO-3101

Issue

Boston Scientific received three reports of embolism that occurred outside of the pelvis. These events occurred as a result of inadvertent placement of Spaceoar gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis. As a result of these three reports, Boston Scientific conducted a comprehensive investigation of all spaceoar embolism complaints received where patient harm was reported. As part of these investigation efforts, Boston Scientific identified potential contributing factors and best practices regarding hydrogel placement during all spaceoar procedures that we are incorporating into the IFU. The updated IFUs will be packaged with Spaceoar systems after all applicable regulatory approvals are obtained for the IFU updates. This product advisory contains the recommended IFU updates.

Recall start date: Feb 24, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Boston Scientific Corporation

300 Boston Scientific Way, Marlborough, Massachusetts

United States, 01752

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63966