Medtronic SynchroMed Implantable Pump Software Safety Alert for Health Establishments
Summary
ANSM has published a safety alert (Ref. R2610621) informing French healthcare establishments of a safety action taken by Medtronic Inc. regarding SynchroMed implantable pumps and associated software for the clinical programming tablet. Users have received a letter dated 16/04/2026 with details of the safety concern and recommended actions.
What changed
ANSM has issued an information notice (Ref. R2610621) regarding a safety action implemented by Medtronic Inc. concerning SynchroMed implantable pumps and their associated programming tablet software/accessories. The safety action was communicated directly to affected users via letter dated 16/04/2026, which is attached to the ANSM notice.
Healthcare establishments using Medtronic SynchroMed pumps should immediately review the Medtronic correspondence to identify affected patients, assess any clinical implications, and implement recommended corrective actions. Medical device manufacturers should monitor for related regulatory scrutiny following this safety communication. Clinical staff should verify whether their facility's pump inventory includes affected SynchroMed models and follow any updated protocols issued by Medtronic.
What to do next
- Consult the Medtronic Inc. letter for specific safety instructions
Archived snapshot
Apr 16, 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.
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Information n° R2610621 destinée aux établissements de santé L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Medtronic Inc.
Les utilisateurs concernés ont reçu le courrier ci-joint.
Cette action de sécurité est enregistrée à l’ANSM sous le n° R2610621.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Medtronic Inc. (16/04/2026)
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