Boston Scientific recalls IceSeed 1.5 CX S needles (April 2024-Feb 2025) that may run in DEMO mode instead of commercial settings, causing system prompts after disconnection. Affected units have specific batch numbers and GTIN.
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 S cryoablation needles made between April 2024 and February 2025 that may run in DEMO mode instead of commercial settings. This could cause the system to prompt for retesting after the needle is disconnected and reconnected, potentially leading to improper treatment if not handled correctly.
The needles are programmed with DEMO settings instead of commercial settings. When disconnected and reconnected to the system, they trigger a re-execution of the Needle Integrity and Functionality Test (NIT), which could lead to improper treatment if the system doesn't complete the test correctly.
Medical professionals using cryoablation systems with these needles during procedures. Patients receiving treatment with affected needles may be at risk of improper freezing or thawing.
Check for batch numbers: 33744602 through 34295233. The needles have a GTIN of 00191506032678 and were sold between April 2024 and February 2025.
Look for batch numbers on the needle packaging or label: 33744602 through 34295233.
Ensure the Cryoablation System is configured for commercial settings, not DEMO mode, before use.
Boston Scientific identified that some IceSeed CX needles were programmed with DEMO settings instead of commercial settings, which could cause the system to prompt for retesting after disconnection.
The system will prompt for re-execution of the Needle Integrity and Functionality Test (NIT), which may lead to improper treatment if not handled correctly.
Check the batch number on the needle label: 33744602 through 34295233. The needles were manufactured between April 2024 and February 2025.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1686-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1686-2025 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.
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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.
