Boston Scientific recalls IceSphere 1.5 90° Cryoablation Needles with reported gas leaks. Affected units have specific batch numbers and UDIs. Consumers should check their device details to determine if recalled.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceSphere 1.5 90° Cryoablation Needles due to reported needle shaft gas leaks. This could potentially cause issues during medical procedures, though the recall does not specify immediate harm.
The needle shaft may leak gas, which could lead to unintended cooling or other complications during medical procedures. However, the recall does not specify that this causes serious injury or death in normal use.
Medical professionals using the IceSphere needle for cryoablation procedures are likely affected. Patients receiving these procedures may be at risk if they have the recalled device.
Check the product label for batch numbers: U1454 to U1802. Also, look for the unique device identifier (UDI) numbers listed: 7290104830945 repeated multiple times.
Review the batch number and unique device identifier (UDI) on the needle to see if it matches the recalled units.
The recall mentions reported gas leaks but does not specify that this causes serious injury or death in normal use. The hazard level is low risk.
Check the batch number (U1454 to U1802) and unique device identifier (UDI) number 7290104830945 on the needle label.
The recall does not provide specific action steps beyond checking if your device matches the listed batch numbers and UDIs.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0670-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0670-2021 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.
