Health Canada Posts OptiCross IVUS Catheter Instruction Correction

Health Canada record; observed October30,2026

A new Canadian posting of an earlier instruction correction

Health Canada published a Type II recall notice on October 29 for specified Boston Scientific OptiCross intravascular ultrasound imaging catheters. The regulator records October 22, 2026 as the recall date; the public posting therefore reports an earlier action rather than a correction initiated on October 29.

The notice, RA-82877, classifies the issue as labelling and packaging. It describes an advisory updating preparation instructions and announcing forthcoming changes to the instructions for use. Its scope is limited to products identified in Attachment 1 of the customer letter.

The public table lists seven catalogue numbers across coronary and peripheral imaging catheters, including OptiCross HD and 6 HD variants. Individual lots are not enumerated there: the table directs readers to the manufacturer for that information. The family name alone is therefore insufficient to determine whether a particular item is included.

Health Canada RA-82877: dates, listed products and advisory scope

AZNO editorial interpretation and evidence limits

Check exact product identity and the customer-letter attachment

For equipment owners, inventory teams and ultrasound-service coordinators, AZNO’s interpretation is to keep the exact catalogue reference, available lot or serial identity, customer-letter attachment and applicable instructions together when checking the notice. A matching product-family label is a starting point for a documentation check, not a completed assessment. Keep any uncertainty about an individual item explicit when contacting the manufacturer.

This report does not reproduce catheter-preparation steps or provide replacement instructions. The current manufacturer letter and product instructions remain the sources for the complete procedure and applicability information. The Canadian posting alone does not establish that every OptiCross unit is affected, that an individual catheter has failed, or that the same action applies in another market. AZNO has not inspected affected items or verified completion of the correction at any facility.