BSX · News · 20260917N
Product Safety Recall
BOSTON SCIENTIFIC CORP · 2026-09-17 · Importance 47 · Surprise 60 · In source text
Boston Scientific initiated a voluntary global recall of the LUX-Dx Insertable Cardiac Monitor System and associated software. The recall concerns delays in atrial fibrillation Burden Alerts, which could affect timely detection and monitoring. The U.S. Food and Drug Administration is taking enforcement interest in the action, increasing regulatory scrutiny of Boston Scientific’s cardiac-monitoring platform.
Key facts
- Boston Scientific has initiated a voluntary global recall of its LUX-Dx Insertable Cardiac Monitor System and associated software due to delays in atrial fibrillation Burden Alerts. source
- The US FDA is taking enforcement interest in this action. source
- The recall adds to existing regulatory risks for Boston Scientific, which also faces other device recalls and product discontinuations. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | negative | committed | — | Boston Scientific has initiated a voluntary global recall of its LUX-Dx Insertable Cardiac Monitor System and associated software due to… |
| operating_income | negative | committed | — | Boston Scientific has initiated a voluntary global recall of its LUX-Dx Insertable Cardiac Monitor System and associated software due to… |