Edwards Lifesciences Swan-Ganz Catheter Recall, 847 Units
Summary
ANSM has recorded a safety action (R2609373) by BD APM (Edwards Lifesciences LLC) involving Swan-Ganz thermodilution catheters. Healthcare establishments have received direct notification of the recall. 847 units are affected by this safety action, which is published on the ANSM portal for visibility.
“L'ANSM a été informée de la mise en œuvre d'une action de sécurité effectuée par la société BD APM (Edwards Lifesciences LLC).”
What changed
ANSM recorded a safety action by BD APM (Edwards Lifesciences LLC) concerning Swan-Ganz thermodilution catheters, affecting 847 units. The action was communicated to affected healthcare establishments via direct letter.\n\nHealthcare facilities that received Swan-Ganz catheters from BD APM should consult the associated communication (reference R2609373) to identify affected lots and take appropriate corrective action. ANSM advises contacting the issuer directly for questions.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Information n° R2609373 destinée aux établissements de santé L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société BD APM (Edwards Lifesciences LLC).
Les utilisateurs concernés ont reçu le courrier ci-joint.
Cette action de sécurité est enregistrée à l’ANSM sous le n° R2609373.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le dossier de la société BD APM (21/04/2026)
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