Boston Scientific recalls IceSeed 1.5 CX Cryoablation Needles made between April 2024 and February 2025 that may operate in DEMO mode instead of commercial settings, potentially causing incorrect function during procedures.
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 is recalling IceSeed 1.5 CX Cryoablation Needles produced between April 2024 and February 2025. These needles may be programmed with DEMO settings instead of commercial settings, which could lead to incorrect function during medical procedures if disconnected and reconnected after testing.
The needles may operate in DEMO mode instead of commercial settings. If disconnected and reconnected after the Needle Integrity and Functionality Test, the system may prompt re-execution of the test, potentially causing incorrect function during procedures.
Medical professionals using the IceSeed 1.5 CX Cryoablation Needles for cryoablation procedures are most at risk. Patients receiving these needles for treatment may be affected if the needles malfunction during procedures.
Check for the product reference number H7493967534170 on the needle packaging. The needles were manufactured between April 2024 and February 2025 with batch numbers including 33988638, 33988639, 34309895, 34309896, 34392269, 34392270, 34392271, or 34564920.
Look for the product reference number H7493967534170 and batch numbers listed in the recall notice.
Boston Scientific identified that some IceSeed 1.5 CX Cryoablation Needles manufactured between April 2024 and February 2025 may be programmed with DEMO settings instead of commercial settings.
If the needle is disconnected and reconnected after the Needle Integrity and Functionality Test, the Cryoablation System may prompt re-execution of the test, potentially causing incorrect function.
Check the product reference number H7493967534170 and batch numbers 33988638, 33988639, 34309895, 34309896, 34392269, 34392270, 34392271, or 34564920 on the needle packaging.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1689-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1689-2025 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
