Boston Scientific IceRod 1.5 90° 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 IceRod 1.5 90° Cryoablation Needles due to reported gas leaks in the needle shaft. This could lead to unintended medical complications during procedures if the device is used without proper leak detection.

Why it’s dangerous

Gas leaks in the needle shaft could cause unintended tissue damage during medical procedures. The leaks may not be immediately noticeable but could lead to complications if the device is used without proper leak detection.

Who’s affected

Medical professionals using the IceRod needle for cryoablation procedures are most at risk. Patients receiving these procedures may also be affected if the device malfunctions.

How to tell if you have this one

Check for the batch numbers U0495, U0498, U0496, U0497, U0420, A0902, or A0903. The product has a unique identifier (UDI) starting with 7290104830242.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Gas Leaks
Inspect the needle shaft for signs of gas leakage before use, as leaks may cause unintended tissue damage during procedures.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

Boston Scientific is recalling these needles due to reported gas leaks in the needle shaft, which could lead to unintended tissue damage during medical procedures.

What batch numbers are affected?

Affected batch numbers are U0495, U0498, U0496, U0497, U0420, A0902, and A0903.

How can I tell if I have the recalled product?

Check the batch number on the product label or the unique identifier (UDI) starting with 7290104830242.

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-0668-2021 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-0668-2021 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-0668-2021 (November 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0668-2021 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 IceRod" 1.5 90¿ Cryoablation Needle

Use caution until it’s fixed