Boston Scientific recalls IceSeed 1.5 CX needles (April 2024-Feb 2025) that may run in DEMO mode instead of commercial settings, causing system prompts during use. Affected needles require specific testing to avoid errors.
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 made between April 2024 and February 2025. These needles may run in DEMO mode instead of commercial settings, which could cause the system to prompt for retesting after disconnection and reconnection. This could lead to incorrect treatment if the system doesn't properly adjust during procedures.
The needles are programmed with DEMO settings instead of commercial settings. When connected to the cryoablation system, they prompt for a Needle Integrity and Functionality Test (NIT). If disconnected and reconnected, the system may require re-execution of the NIT, potentially causing incorrect treatment settings during procedures.
Medical professionals using cryoablation systems with these specific needles are most at risk. Patients receiving procedures with affected needles may experience incorrect treatment outcomes.
Check for the product name 'IceSeed 1.5 CX NEEDLE US' with the reference number H7493967433170. The needles were manufactured between April 2024 and February 2025 and have specific batch numbers listed in the recall notice.
Verify that the IceSeed CX needle is operating in commercial settings, not DEMO mode, by checking the system prompts during initial connection.
Complete the Needle Integrity and Functionality Test (NIT) as prompted by the system to ensure proper functionality before use.
Boston Scientific identified that some IceSeed 1.5 CX needles were programmed with DEMO settings instead of commercial settings, which could cause the system to prompt for retesting after disconnection and reconnection.
No, but you must verify the settings and complete the NIT test as prompted by the system to ensure proper functionality.
The affected batch numbers are 33744276, 33744277, 33744278, 33931638, 33931639, 33931900, 33980480, 33980481, 33980482, 33989380, 33989381, 33989382, 34063066, 34063067, 34063068, 34063069, 34063070, 34084080, 34084081, 34084084, 34094111, 34094112, 34110333, 34110334, 34110335, 34110336, 34110337, 34168777, 34168778, 34204925, 34204926, 34204927, 34295709.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1688-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1688-2025 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.
