Urgent Field Safety Notice For Infinion Cx By Boston Scientific Neuromodulation Corporation

Recall Summary Boston Scientific Neuromodulation Corporation is issuing an urgent field safety notice for the Infinion CX device due to an identified risk. This is a Class I recall, meaning the most serious type. The notice applies to devices distributed in Germany and the European Union.

Recalling firm

Urgent Field Safety Notice for Infinion CX by Boston Scientific Neuromodulation Corporation , Download_VeroeffentlichtAm

Product

s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for Infinion CX by Boston Scientific Neuromodulation Corporation 2026

Reason

assessment Field corrective actions Urgent Field Safety Notice for Infinion CX by Boston Scientific Neuromodulation Corporation 2026

Classification

Class I

Category

medical device recall

Country

Germany

Agency

BFARM

Recall date

2026-06-19

Status

Ongoing

Distribution

Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/2d6076fc-eadd-4aed-9ca0-11d33adfc245