Cre™ Wireguided And Cre Pro™ Wireguided Balloon Dilation Catheters

Recall Summary CRE™ Wireguided and CRE PRO™ Wireguided Balloon Dilation Catheters are being recalled across Canada due to a sterility concern. These medical devices are used for balloon dilation procedures. The recall is classified as Class II, meaning the devices could potentially cause adverse health effects but are not expected to cause serious injury.

Product

CRE™ Wireguided and CRE PRO™ Wireguided Balloon Dilation Catheters

Reason

Sterility concern

Classification

Class II

Category

medical device recall

Country

Canada

Agency

HC-DEVICES

Recall date

2026-05-29

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/4d8af85b-ec94-4bad-b73e-01d6f863e3ce