- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.
- Affected products (lot / model / serial)
- Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;
- Units affected
- 403
- Distribution pattern
- US Nationwide distribution in the states of AL, CA, FL, GA, IL, IN, KY, MD, NC, NH, NM, NY, RI, TX, WA, WI, WV and the countries in TBD.
- Firm location
- Marlborough, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0143-2027
- Recall initiated
- September 10, 2026
- FDA classification date
- October 9, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99829
- Last updated on HTM Vibe
- October 27, 2026
