Advanced Bionics Cochlear Implant Battery Compartment Recall, 847 Units
Summary
ANSM recorded a lot withdrawal by Advanced Bionics LLC for cochlear implant battery compartments (model ZN Air M CI-5501). The action, registered as R2609192, affects 847 units. Health establishments received direct notification from the company with instructions for identifying and returning affected devices.
What changed
Advanced Bionics LLC initiated a lot withdrawal for cochlear implant battery compartments (ZN Air M CI-5501) affecting 847 units, recorded by ANSM under reference R2609192. The company's safety communication dated 09/04/2026 provides specific instructions for affected health establishments to identify and manage the impacted devices.
Healthcare providers and medical device distributors must immediately verify whether any affected units are in their possession, follow the manufacturer's return instructions, and monitor patients for any device-related adverse events. As a bound regulatory enforcement action by the French medicines agency, non-compliance with recall procedures may carry operational and legal consequences.
What to do next
- Identify any affected Advanced Bionics CI-5501 battery compartments in inventory
- Contact Advanced Bionics LLC directly using the provided notification letter
- Report any adverse incidents related to the affected devices to ANSM
Archived snapshot
Apr 9, 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.
Rappel n° R2609192 destiné aux établissements de santé L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectué par la société Advanced Bionics LLC.
Les établissements de santé concernés ont reçu le courrier ci-joint.
Cette action de sécurité est enregistrée à l’ANSM sous le n° R2609192. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Advanced Bionics LLC (09/04/2026)
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