Boston Scientific IceRod i-Thaw Prostate Cryoablation Kit Recall: Needle Gas Leaks

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Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Boston Scientific is recalling IceRod i-Thaw Prostate Cryoablation Kits due to reported needle shaft gas leaks. This could lead to improper treatment or injury during medical procedures. Owners should stop using the kit immediately.

Why it’s dangerous

The needle shaft in the kit may leak gas, which could cause improper freezing of tissue during treatment. This might lead to incomplete procedures or unintended tissue damage.

Who’s affected

Patients undergoing prostate cryoablation procedures who own the recalled kit. Medical professionals using the kit are also at risk if they have the affected units.

How to tell if you have this one

Check for batch numbers listed in the recall (e.g., U1423, U1422) or Unique Device Identifiers (UDIs) like 7290104830983. The kit is sold under the brand name IceRod i-Thaw.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
If you own the recalled IceRod i-Thaw Prostate Cryoablation Kit, stop using it right away to avoid potential risks.

✎ GovInfoNow

Questions people ask

What is the specific hazard with this kit?

The kit has reported needle shaft gas leaks, which could cause improper tissue freezing during medical procedures.

How can I check if my kit is affected?

Check the batch numbers listed in the recall (e.g., U1423, U1422) or Unique Device Identifiers (UDIs) like 7290104830983.

Do I need to return the kit?

The recall record does not specify a return process, so contact Boston Scientific directly for 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-0686-2021 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-0686-2021 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-0686-2021 (November 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0686-2021 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" i-Thaw" Prostate Cryoablation Kit

Lower-risk recall