Boston Scientific recalls IceSphere 1.5 CX 90° Cryoablation Needles with reported gas leaks. Affected units have specific batch numbers and UDIs. Consumers should check their product details to determine if recalled.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceSphere 1.5 CX 90° Cryoablation Needles due to reported gas leaks in the needle shaft. This could potentially cause issues during medical procedures if the needle leaks gas.
The needle shaft has reported gas leaks, which could lead to improper medical procedures if the device leaks gas during use. However, the leaks are not described as causing serious injury in normal use.
Medical professionals who use the IceSphere 1.5 CX 90° Cryoablation Needle for procedures. Patients using this device are not directly affected as it's a medical tool.
Check for the product name 'IceSphere 1.5 CX 90° Cryoablation Needle' with batch numbers listed in the recall (e.g., U1458, U1457, etc.) or Unique Device Identifiers (UDIs) starting with 7290104831133.
Review your product's batch number and Unique Device Identifier (UDI) to see if it matches the listed numbers in the recall.
The recall is based on reported gas leaks in the needle shaft, but the device is not described as causing serious injury in normal use. It may be safe for use if the leak is not present.
Check the batch number or Unique Device Identifier (UDI) on your product against the list provided in the recall notice.
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-0664-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0664-2021 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.
