Open official notice

Safety warnings concerning OptiCross IVUS catheters to reduce the risk of air embolism by modifying the instructions for use regarding flushing and air management procedures.

Official notice

5 Nov 2026

Last checked

5 Nov 2026

RecallScope risk estimate:Not specifiedAEMPS

An official AEMPS notice concerns Safety warnings concerning OptiCross IVUS catheters to reduce the risk of air embolism by modifying the instructions for use regarding flushing and air management procedures.. Safety warnings concerning OptiCross IVUS catheters to reduce the risk of air embolism by modifying the instructions for use regarding flushing and air management procedures. Published 2026-11-05.

What to do now

Consumer instructions are not currently available in RecallScope. Check the official notice for what to do.

Recall number

2026-536

Official notice

2026-11-05

The hazard

Safety warnings concerning OptiCross IVUS catheters to reduce the risk of air embolism by modifying the instructions for use regarding flushing and air management procedures.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Check the official notice for the affected products and next steps.

Other

PS/EML/145990

Recall Numbers

2026-536

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Affected products

Product 1

Catéteres para la obtención de imágenes por ecografía intravascular (IVUS) OptiCross.

Hazard

Safety warnings concerning OptiCross IVUS catheters to reduce the risk of air embolism by modifying the instructions for use regarding flushing and air management procedures.

Where it was sold

Retailer information is not currently available in RecallScope. Check the official notice for distribution details.

Location 1

ES · Spain

Affected area 1

ES · Spain

Source & status

Source

Tier

official

Category

HEALTH

Official classification

AEMPS — Alerta de vigilancia de productos sanitarios (tipo 2A)

Recall details

Recall number

2026-536

Event id

2026-536

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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