Boston Scientific recalls IceRod 1.5 CX 90° Cryoablation Needles with reported gas leaks. Affected units have specific UDI and batch numbers. Consumers should check their product details and contact Boston Scientific for guidance.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceRod 1.5 CX 90° Cryoablation Needles due to reported gas leaks in the needle shaft. This could potentially cause issues during medical procedures. Affected units have specific unique device identifiers and batch numbers.
The needle shaft has reported gas leaks, which could lead to potential issues during medical procedures. However, the risk is not described as causing serious injury in normal use.
Medical professionals who use the IceRod 1.5 CX 90° Cryoablation Needles are most likely affected. The recall involves specific batch numbers and unique device identifiers.
Check if your IceRod 1.5 CX 90° Cryoablation Needle has a unique device identifier (UDI) listed in the provided numbers or a batch number from the list of batch numbers provided.
Review your IceRod 1.5 CX 90° Cryoablation Needle's unique device identifier (UDI) or batch number against the provided lists.
Boston Scientific is recalling IceRod 1.5 CX 9:00 Cryoablation Needles with reported gas leaks in the needle shaft.
Check your product's unique device identifier (UDI) or batch number against the lists provided in the recall notice.
Contact Boston Scientific for guidance on next steps; no specific remedy is stated in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0663-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0663-2021 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.
