Changeflow GovPing Healthcare & Life Sciences IVascular Navitian Coronary Microcatheter Recall
Urgent Enforcement Removed Final

IVascular Navitian Coronary Microcatheter Recall

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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.

Published by ANSM on ansm.sante.fr . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

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

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

Archived snapshot

Apr 7, 2026

GovPing 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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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)

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Last updated

Classification

Agency
ANSM
Filed
April 7th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2607706/R2609369

Who this affects

Applies to
Healthcare providers Hospitals & Health Systems
Industry sector
3345 Medical Device Manufacturing 6211 Healthcare Providers
Activity scope
Medical Device Distribution Medical Device Recall
Geographic scope
France FR

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Compliance frameworks
FDA 21 CFR Part 11
Topics
Healthcare Product Safety

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