Boston Scientific recalls IceSphere 1.5 S 90° Cryoablation Needles with reported gas leaks. Affected units have specific batch numbers and UDIs. Consumers should contact for details.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceSphere 1.5 S 90° Cryoablation Needles due to reported gas leaks in the needle shaft. This could potentially cause issues during medical procedures if the leak occurs under pressure.
The needle shaft may leak gas, which could cause unintended pressure changes during medical procedures. This might lead to complications if the leak occurs while the needle is in use.
Medical professionals using the IceSphere needle for cryoablation procedures are most at risk. Patients receiving these procedures may also be affected if the needle leaks during treatment.
Check for batch numbers U1176, U1175, U0460, U0459, U0157, T0702, T0389, T0390, T0371, T0370, T0064, T0065, T0045, T0044, A7075, A7074, A6873, A6872, A1632, A1633, A1616, A1615, A1363, A1364 on the needle. Also look for unique device identifiers (UDIs) starting with 7290104830556.
Identify the batch number and unique device identifier (UDI) on the needle to confirm if it's affected.
Boston Scientific is recalling these needles due to reported gas leaks in the needle shaft, which could cause unintended pressure changes during medical procedures.
Check the batch number on the needle (U1176, U1175, U0460, etc.) and the unique device identifier (UDI) starting with 7290104830556.
Contact Boston Scientific directly to confirm if your needle is affected and get instructions on next steps.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0672-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0672-2021 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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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.
