Boston Scientific IceRod 1.5 i-Thaw Cryoablation Needle Recall: Gas Leak Risk

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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 1.5 i-Thaw Cryoablation Needles due to reported gas leaks in the needle shaft. This could lead to unintended medical complications during procedures.

Why it’s dangerous

The needle shaft may leak gas, which could cause unintended medical complications during procedures. This is a complaint trend, not confirmed to cause injuries.

Who’s affected

Medical professionals using the IceRod 1.5 i-Thaw Cryoablation Needle for procedures are most at risk. Patients using the device are not directly affected by the recall.

How to tell if you have this one

Check for batch numbers: U1362, U1217, U0957, U0283, U0282, U0087, T0819, T0392, A6883, A6657, A2043, A1954, A1669, A1532, A1501, A1476, A1329. Also look for unique device identifiers (UDIs) starting with 7290104830204.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Identify your needle's batch number and unique device identifier (UDI) to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

The recall is based on complaint trends of needle shaft gas leaks, but no injuries have been reported. It's considered low risk.

How do I know if my needle is affected?

Check for batch numbers: U1362, U1217, U0957, U0283, U0282, U0087, T0819, T0392, A6883, A6657, A2043, A1954, A1669, A1532, A1501, A1476, A1329. Also look for UDIs starting with 7290104830204.

What should I do if I have an affected needle?

The recall does not specify a remedy. 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-0665-2021 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-0665-2021 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-0665-2021 (November 18, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0665-2021 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 i-Thaw" Cryoablation Needle

Lower-risk recall