IVascular Navitian Coronary Microcatheter Recall

ANSM Drug & Device Safety Alerts

Filed April 7th, 2026

Detected April 7th, 2026

Summary

ANSM issued a medical device safety recall (R2607706/R2609369) for IVascular Navitian coronary microcatheters manufactured by Life Vascular Device Biotech S.L. The recall affects specific lots and targets pharmacies and healthcare establishments in France. Users should immediately quarantine and return affected products following the manufacturer's instructions.

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What changed

ANSM has issued a product recall notification for IVascular Navitian coronary microcatheters distributed by Life Vascular Device Biotech S.L. The recall, registered under reference numbers R2607706/R2609369, was initiated after the agency was informed of a lot-specific withdrawal action by the manufacturer. The recall applies to pharmacies and healthcare establishments.\n\nHealthcare facilities must immediately check their inventory for affected microcatheter lots, quarantine any products matching the recalled batch numbers, and follow the return procedures specified in the manufacturer's letter dated 07/04/2026. Contact the manufacturer directly for questions regarding the recall and return process.

What to do next

Identify and quarantine any IVascular Navitian coronary microcatheters matching the recalled lots in inventory
Do not use affected microcatheters for patient procedures
Return quarantined products to Life Vascular Device Biotech S.L. following manufacturer instructions

Source document (simplified)

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Rappel n° R2607706/R2609369 destiné aux pharmacies d'usage intérieur et aux établissements de santé L'ANSM a été informée de la mise en œuvre d’un retrait de lot effectué par la société Life Vascular Device Biotech S.L.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607706/R2609369. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Life Vascular Device Biotech S.L (07/04/2026)