Boston Scientific recalls IceSphere 1.5 Cryoablation Needles due to reported gas leaks. Affected units have specific batch and UDI numbers. Contact for return instructions.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceSphere 1.5 Cryoablation Needles after complaints about needle shaft gas leaks. This could lead to unintended medical complications during procedures.
Gas leaks in the needle shaft could cause unintended tissue damage during medical procedures. This might lead to complications like bleeding or infection if the leak occurs during treatment.
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 gas.
Check for the batch number A0125 and UDI number 07290104830211 on the needle packaging. The product was sold with the UPN FPRPR3258.
Look for the batch number A0125 and UDI number 07290104830211 on the needle packaging.
The recall is based on complaints about needle shaft gas leaks, which could lead to unintended tissue damage during procedures. However, the hazard level is low risk as no injuries have been reported.
Check for the batch number A0125 and UDI number 07290104830211 on the needle packaging. The product was sold with the UPN FPRPR3258.
The recall record does not specify a remedy, so contact Boston Scientific directly for 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-0674-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0674-2021 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.
