PMDA notice: Class I voluntary recall, RelayPro thoracic stent graft system
「医療機器自主回収のお知らせ（クラスI）（販売名：RelayPro 胸部ステントグラフトシステム）」を掲載しました
Published: 2026-06-01 · Source: Pharmaceuticals and Medical Devices Agency (PMDA) — Safety Updates · Stage: Government Announcement · Area: Healthcare / Pharmaceuticals · Impact (preliminary): Medium · First detected by this dashboard: 2026-08-06
View the original Japanese source More Healthcare / Pharmaceuticals updates Search all updates in the dashboard
AI summary
Generated by AI from the Japanese source metadata. It is an unofficial monitoring aid, not legal advice, and may contain errors. The area, stage, and impact labels are preliminary keyword-based triage labels. Confirm every point in the original Japanese source.
Summary
The PMDA safety information page lists a notice titled as a voluntary recall (Class I) of a medical device sold under the name 'RelayPro Thoracic Stent Graft System'. The item was published on 2026-06-01 and is a government announcement posted on the PMDA site. The provided metadata does not include the reason for the recall, affected lots, or the recall scope.
Business Impact
Manufacturers, importers, distributors, and healthcare facilities handling this product may need to check whether the recall affects them. Class I is generally the most serious recall classification, so the notice could carry significant implications for those involved.
Recommended Action
Review the official Japanese PMDA notice at the source URL to confirm the recall reasons, affected products, and any requested actions.