Every recalls & safety alerts report published for SAINT PAUL, Minnesota, newest first.
An FDA enforcement report lists the Class II recall, initiated June 11, 2026, as ongoing, citing hemostatic valve damage linked to dilator insertion during device preparation.
An FDA enforcement report lists a Class II action covering six pulsed field ablation generators distributed in five European countries.
An FDA enforcement report lists the Class II action, initiated June 11, 2026, as ongoing after devices shipped with instructions omitting FARAPOINT PFA catheter information.
An FDA enforcement report says instructions supplied with the device omitted FARAPOINT PFA catheter information; the Class II action is listed as ongoing.
An FDA enforcement report classifies the ongoing Class II action, which covers units distributed in nine European countries, as a labeling discrepancy.