FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

CE Mark Suspended on GI Dynamics’ EndoBarrier

May 19, 2017

GI Dynamics has received notification that the CE Mark for its EndoBarrier system was suspended due to nonconformances related to its quality management system.

The company said the required corrective action was unrelated to the safety or efficacy of the product, and it does not constitute a recall.

Implanted patients may continue treatment subject to normal ongoing evaluation and monitoring by their healthcare professional. The company said it has shipped sufficient inventory to its customers to ensure uninterrupted service during the suspension.  — Cynthia Jessup

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