Boston Scientific recalls IceSphere 1.5 90° Cryoablation Needles with gas leaks. Affected units have specific batch numbers and UDIs. Consumers should contact the company for details.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceSphere 1.5 90° Cryoablation Needles due to reported gas leaks in the needle shaft. This could lead to potential safety issues during medical procedures.
The needle shaft may leak gas, which could cause unintended cooling or other complications during medical procedures. This is a complaint trend but not confirmed as a direct hazard.
Medical professionals using the IceSphere needles for cryoablation procedures are most at risk. Patients receiving these procedures may also be affected if the needles are used.
Check for batch numbers U0326, U0325, U0286, U0285, A7012, or A7011 on the needle packaging. The unique device identifiers (UDIs) listed are 07290104830259.
Look for batch numbers U0326, U0325, U0286, U0285, A7012, or A7011 on the needle packaging.
Complaints about gas leaks in the needle shaft, which could lead to potential safety issues during medical procedures.
Check for batch numbers U0326, U0325, U0286, U0285, A7012, or A7011 on the packaging. The unique device identifiers (UDIs) are 07290104830259.
The recall does not specify a remedy, so contact Boston Scientific directly for further instructions.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0673-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0673-2021 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.
