Health product recall

Rotawire Drive Guidewire And Wireclip Torquer

Last updated

Summary

Product
Rotawire Drive Guidewire And Wireclip Torquer
Issue
Medical devices - Quality issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Rotawire Drive Guidewire And Wireclip Torquer, Extra Support

More than 10 numbers, contact manufacturer.

H74939463005

Rotawire Drive Guidewire And Wireclip Torquer, Floppy

More than 10 numbers, contact manufacturer.

H74939462005

Issue

Boston Scientific is conducting a removal of specific batches of rotawire drive and wireclip torquer after determining that a small number of pouches containing these products may have a weak seal, which could open during normal shipping and handling and thus compromise the sterile barrier. Use of a rotawire drive product from a package with a sterile barrier breach may present a risk of infection. The most serious health risk that could occur from use of a non-sterile rotawire drive is a post-procedure endocarditis or access site infection that could be managed with medical evaluation and treatment with oral or intravenous antibiotics. We have received one complaint related to this issue and there have been no patient harms or adverse events reported.

Recall start date: Mar 8, 2022

Additional information

Details
Original published date: 2022-03-17
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
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-63998