Boston Scientific recalls IceSphere 1.5 Cryoablation Needles with reported gas leaks. Affected units have specific batch numbers and UDIs. Consumers should contact for details.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceSphere 1.5 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 may leak gas, which could cause issues during medical procedures. This is a complaint trend but not confirmed as causing injuries or serious harm in normal use.
Medical professionals using the IceSphere 1.5 Cryoablation Needle for procedures are likely affected. Patients receiving these needles may be at risk if the leak occurs during treatment.
Check for batch numbers: U1403, U1218, U0295, U0215, U0182, U0153, U0047, T0674, T0463, T0129, A7010, A6956, A6893, A6738, A2102, A1185. Also look for unique device identifiers (UDIs) starting with 7290104830938.
Identify your needle's batch number and unique device identifier (UDI) to confirm if it's affected.
The recall is based on complaint trends about gas leaks in the needle shaft, but no injuries or serious harm have been reported. The risk is low.
Check the batch number on your needle (U1403, U1218, U0295, U0215, U0182, U0153, U0047, T0674, T0463, T0129, A7010, A6956, A6893, A6738, A2102, A1185) and the unique device identifier (UDI) starting with 7290104830938.
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-0671-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0671-2021 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.
