Open official notice

Recall of certain Saluda Evoke implantable spinal cord stimulators, due to the possibility of unintended stimulation during charging or the inability of the implanted product to receive a charge from the charging system.

Official notice

4 Nov 2026

Last checked

4 Nov 2026

RecallScope risk estimate:Not specifiedAEMPS

An official AEMPS notice concerns Recall of certain Saluda Evoke implantable spinal cord stimulators, due to the possibility of unintended stimulation during charging or the inability of the implanted product to receive a charge from the charging system.. Recall of certain Saluda Evoke implantable spinal cord stimulators, due to the possibility of unintended stimulation during charging or the inability of the implanted product to receive a charge from the charging system. Published 2026-11-04.

What to do now

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

Recall number

2026-534

Official notice

2026-11-04

The hazard

Recall of certain Saluda Evoke implantable spinal cord stimulators, due to the possibility of unintended stimulation during charging or the inability of the implanted product to receive a charge from the charging system.

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

UDI-DI 09352307001282, PS/AVG/145490

Part Numbers

1042

Recall Numbers

2026-534

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Affected products

Product 1

Estimuladores medulares implantables Saluda Evoke Closed Loop Stimulators (CLS).

Product 2

Número de referencia: 1042. UDI-DI: 09352307001282

Hazard

Recall of certain Saluda Evoke implantable spinal cord stimulators, due to the possibility of unintended stimulation during charging or the inability of the implanted product to receive a charge from the charging system.

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

2026-534

Event id

2026-534

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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