Boston Scientific IceSeed 1.5 Cryoablation Needle Recall: Gas Leak Risk

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Contact the company & request your remedy

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Boston Scientific is recalling IceSeed 1.5 Cryoablation Needles due to reported gas leaks in the needle shaft. This could lead to injury during medical procedures if the device fails unexpectedly.

Why it’s dangerous

The needle shaft may leak gas, which could cause unexpected pressure changes during medical procedures. This might lead to injury if the device malfunctions while in use.

Who’s affected

Medical professionals using the IceSeed needle for cryoablation procedures are most at risk. Patients receiving the device during treatment may also be affected.

How to tell if you have this one

Check the product's batch numbers: U0181, T0393, A6912, A6664, A1915, A1072, A1024, A0853, or A0574. Also look for the unique device identifiers (UDIs) listed as 7290104830181.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discontinue use of the IceSeed 1.5 Cryoablation Needle if it has the listed batch numbers or UDIs.

✎ GovInfoNow

Questions people ask

Why is this needle being recalled?

Boston Scientific recalls the IceSeed 1.5 Cryoablation Needle due to reported gas leaks in the needle shaft.

How can I check if my needle is affected?

Check the batch numbers (U0181, T0393, A6912, A6664, A1915, A1072, A1024, A0853, A0574) or unique device identifiers (UDIs) listed as 7290104830181.

What should I do if I have the affected needle?

Stop using the needle immediately and contact Boston Scientific for further instructions.

Take action

Contact Boston Scientific

We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0676-2021 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-0676-2021 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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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-0676-2021 (November 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0676-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.

Boston Scientific Corporation recalls IceSeed" 1.5 Cryoablation Needle

Use caution until it’s fixed