PMDA Notice: Class I Recall, RelayPro Thoracic Stent Graft System
クラスI回収 該当回収品目 RelayPro 胸部ステントグラフトシステム
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 Pharmaceuticals and Medical Devices Agency (PMDA) safety updates page lists a Class I recall entry for the RelayPro thoracic stent graft system, dated 2026-06-01. The provided metadata contains only the Japanese title and a generic page description; the reason for the recall, affected lots, and required actions are not stated.
Business Impact
Manufacturers, importers, distributors, and healthcare facilities handling this device may need to check whether they hold affected products and how the recall applies to them. Class I is generally the highest-risk recall classification, but specifics cannot be confirmed from the provided metadata.
Recommended Action
Review the official PMDA notice and any linked recall details in Japanese to confirm the affected products, scope, and instructions.