PharmacovigilanceOfficial

Boston Scientific updates flushing instructions for OptiCross intravascular ultrasound imaging catheters in Canada

🇨🇦 Health Canada · Thu 29 Oct 2026

Health Canada lists a Type II recall of OptiCross catheters covering revised flushing guidance, reinforced air-management practices and forthcoming Instructions For Use updates.

Health Canada has published a Type II health product recall for the OptiCross family of intravascular ultrasound (IVUS) imaging catheters made by Boston Scientific Corporation. The recall date is 22 October 2026, and the notice was posted on 29 October 2026 under identification number RA-82877.

According to the notice, the manufacturer is issuing an advisory to communicate an update to the flushing instructions. It also aims to reinforce device preparation and air-management practices, and to tell users that updates to the Instructions For Use (IFU) are coming. Health Canada classes the issue under medical devices, labelling and packaging.

The advisory applies only to the products listed in attachment 1 of the customer letter. Health Canada's list covers the OptiCross Coronary Imaging Catheter, the OptiCross 35 15mhz Peripheral Imaging Catheter, the OptiCross 18 Peripheral Imaging Catheter, and OptiCross 6 HD and OptiCross HD models. Each entry carries the note that more than 10 lot or serial numbers are affected, so users must contact the manufacturer for them. Listed catalogue numbers include H749518120, H7493932800350, H74939354080, H74939354090, H74939352040, H74939352050 and H7493932700180.

The notice is aimed at healthcare audiences. Its only instruction is to contact the manufacturer for additional information. It does not describe any adverse events, a root cause or a timeline for the revised IFU. In general, a Type II recall in Canada concerns products that may cause temporary or medically reversible health effects, or where serious adverse consequences are unlikely.

What it means for your team

  • Healthcare facilities using OptiCross catheters should contact Boston Scientific to obtain the full lot and serial number lists, which Health Canada does not publish.
  • Quality and clinical teams should expect revised IFU and flushing instructions, and should plan to review preparation and air-management procedures once these arrive.
  • Regulatory teams should note that the notice gives no detail on reported incidents or root cause, so the manufacturer's customer letter is the key source for further information.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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