- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.
- Affected products (lot / model / serial)
- UDI-DI: 00802526613838
- Units affected
- N/A
- Distribution pattern
- Worldwide - US Nationwide distribution.
- Firm location
- Saint Paul, MN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3081-2026
- Recall initiated
- August 6, 2026
- FDA classification date
- September 2, 2026
- FDA report date
- September 9, 2026
- FDA event ID
- 99524
- Last updated on HTM Vibe
- September 15, 2026