Boston Scientific Corporation recalls IceSeed 1.5 CX S NEEDLE US

Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

Boston Scientific issued a Product Advisory notice to its consignees on 03/24/2025 via Fed Ex, email, and hand delivery. The notice explained the issue, clinical impact, and provided the following recommendations: " Avoid disconnecting and reconnecting these IceSeed CX Cryoablation Needles from/to the Cryoablation System. " Maintain initial connection of IceSeed CX Cryoablation Needles to the Cryoablation System and the IceSeed CX Cryoablation Needles will perform as intended. The consignee was also directed to immediately post this information in a visible location near the affected products to ensure it is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any entities where the affected devices may have been transferred and complete the acknowledgement form and return it to BSCFieldActionCenter@bsci.com (email) or Fax to: Field Action Center 1-763-415-7708.

• FDA enforcement recordOfficial FDA database entry for Z-1686-2025
• FDA 510(k) clearance · K232635The device's official FDA premarket clearance record
• FDA device classification · GEHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4350The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Boston Scientific CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.