Boston Scientific recalls IceSeed 1.5 CX S needles with DEMO settings that may cause system errors if disconnected and reconnected after testing. Affected units sold between April 2024 and February 2025.
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 that were programmed with DEMO settings instead of commercial settings. This could cause the system to prompt re-execution of the Needle Integrity Test if the needle is disconnected and reconnected after testing, potentially leading to incorrect treatment.
The needles are programmed with DEMO settings instead of commercial settings. If the needle is disconnected and reconnected after the initial test, the system will prompt re-execution of the Needle Integrity Test, which could lead to incorrect treatment parameters.
Medical professionals using the IceSeed 1.5 CX S needles for cryoablation procedures are most at risk. Patients receiving these needles for freezing or thawing treatments may be affected if the system malfunctions.
Check for the product name 'IceSeed 1.5 CX S NEEDLE OUS' with the GTIN 00191506032685. Affected units were manufactured between April 2024 and February 2025 with batch numbers 33996437 through 34564921.
If the needle prompts re-execution of the Needle Integrity Test after disconnection and reconnection, it is affected.
Boston Scientific identified that some IceSeed 1.5 CX S needles were programmed with DEMO settings instead of commercial settings, which could cause system errors if disconnected and reconnected after testing.
Check for the product name 'IceSeed 1.5 CX S NEEDLE OUS' with GTIN 00191506032685 and batch numbers 33996437 through 34564921, manufactured between April 2024 and February 2025.
No, but if the needle prompts re-execution of the Needle Integrity Test after disconnection and reconnection, it is affected and should be checked.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1687-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1687-2025 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.
