Boston Scientific recalls IceEDGE 2.4° 90° Cryoablation Needles with 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 IceEDGE 2.4° 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 may leak gas, which could cause unintended cooling or other complications during medical procedures. This is a complaint trend, not a confirmed hazard in all cases.
Medical professionals using the IceEDGE needles for cryoablation procedures are most at risk. Patients using these needles under medical supervision may also be affected.
Check for batch numbers: U0288, U0287, U0062, U0060, T0433, T0434, T0416, T0417, X6836, A6781, A6782, A6762, A6761, A2078, A2079, A1529, A1373, A1374. Also look for unique device identifiers (UDIs) starting with 7290104830594.
Identify your needle's batch number and unique device identifier (UDI) to confirm if it's affected.
Boston Scientific is recalling these needles due to complaints about gas leaks in the needle shaft.
Check the batch number on your needle (U0288, U0287, U0062, U0060, T0433, T0434, T0416, T0417, X6836, A6781, A6782, A6762, A6761, A2078, A2079, A1529, A1373, A1374) and the unique device identifier (UDI) starting with 7290104830594.
Contact Boston Scientific directly to confirm if your needle is affected and follow their 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-0677-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0677-2021 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.
