Use caution Medical device recall · FDA · Published March 24, 2025

Boston Scientific IceSeed CX Needles: DEMO Settings Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1687-2025Medical device Boston Scientific ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmBoston Scientific Corporation1 Scimed Pl · Maple Grove, MN 55311-1565

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/52539-boston-scientific-iceseed-cx-needles-demo-settings-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/52539-boston-scientific-iceseed-cx-needles-demo-settings-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1687-2025

Cite this page

“Boston Scientific IceSeed CX Needles: DEMO Settings Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52539-boston-scientific-iceseed-cx-needles-demo-settings-risk. Based on FDA recall #Z-1687-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1687-2025%22&limit=1).

The Food and Drug Administration announced on March 24, 2025, that Boston Scientific Corporation is recalling IceSeed 1.5 CX S NEEDLE OUS cryoablation needles due to programming errors. The agency stated the recall is voluntary and classified as Class II.

How to tell if you have it

IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100
UPC 00191506032685
Batch Numbers: 33996437, 33996438, 34295231, 34295232, 34392272, 34392273, 34392274, 34564921
Manufactured between April 2024 and February 2025

The hazard

According to the FDA, affected needles were programmed with DEMO settings instead of Commercial settings. The needles perform as intended unless disconnected and reconnected after testing, in which case the system prompts a re-execution of the Needle Integrity and Functionality Test.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent recalls include the August 24, 2026, recall of Imager II Angiographic Catheters for tip fracture risk and the August 6, 2026, recall of LUX-Dx Cardiac Monitor Systems for delayed AF burden alerts. Other recent recalls of similar products include the April 29, 2026, CSK Electrodes recall for performance levels, the April 22, 2026, Intracept Access Instruments recall for sterility breach risk, and the April 29, 2026, TCN Electrodes recall for performance issues.

How to tell if you have this one

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.

Brand
Boston Scientific
Product
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide

Recall number	Product, codes & lots	Quantity
Z-1686-2025	IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.; GTIN 00191506032678, Batch Numbers: 33744602, 33744603, 33744604, 33744605, 33931901, 33937786, 33937787, 33942987, 33942988, 33942989, 33950417, 33950418, 33996423, 33996424, 33996428, 34038291, 34038292, 34038307, 34117281, 34128141, 34128142, 34151877, 34151878, 34204928, 34204929, 34256930, 34256931, 34256932, 34295233.	435 units
Z-1687-2025	IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.; GTIN 00191506032685, Batch Numbers: 33996437, 33996438, 34295231, 34295232, 34392272, 34392273, 34392274, 34564921.	31 units
Z-1688-2025	IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.; GTIN 00191506032692, Batch Numbers: 33744276, 33744277, 33744278, 33744600, 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.	244 units
Z-1689-2025	IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application.; GTIN00191506032708, Batch Numbers: 33988638, 33988639, 34309895, 34309896, 34392269, 34392270, 34392271, 34564920.	67 units

Based on the official FDA remedy

What to do — step by step

Check Needle Integrity Test
If the needle prompts re-execution of the Needle Integrity Test after disconnection and reconnection, it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 44 days after the firm started it.

Mar 24, 2025Firm started the recall
Apr 29, 2025FDA classified it Class II
May 7, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/52539-boston-scientific-iceseed-cx-needles-demo-settings-risk">Boston Scientific IceSeed CX Needles: DEMO Settings Risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1687-2025 (March 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1687-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.