Official recall record
OptiCross Intravascular Ultrasond Imagine Catheters
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-10-29
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Boston Scientific is providing this advisory regarding the OptiCross™ family of intravascular ultrasound (IVUs) imaging catheters to communicate an update to the flushing instructions, reinforce device preparation and air-management practices, and inform users of upcoming updates to the Instructions For Use (IFU). This advisory applies only to the products listed in attachment 1 from the customer letter.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-11-08.
Record last checked against the registry on 2026-11-08.
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