Boston Scientific recalls IceRod 1.5 MRI Cryoablation Needles with reported gas leaks. Affected units have specific batch numbers and UDIs. Consumers should contact the company for details.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceRod 1.5 MRI Cryoablation Needles due to reported gas leaks in the needle shaft. This could potentially cause issues during medical procedures. Affected units have specific batch numbers and unique device identifiers.
The needle shaft may leak gas, which could cause unintended cooling or other complications during medical procedures. This is a reported issue but the exact risk level is not specified in the recall notice.
Medical professionals using the IceRod 1.5 MRI Cryoablation Needles are likely affected. Patients undergoing procedures with these needles may be at risk if the device has a gas leak.
Check for batch numbers: U1440, U1441, U1311, U1312, U1015, U1016, U0462, U0461, U0050, U0030, T0520, T0521, T0157, T0158, A7135, A7134, A6987, A6986, A6707, A6708, A6689, A6688, A1730, A1731, A1149, A1150. Also look for unique device identifiers (UDIs) starting with 7290104830273.
Identify your batch number and unique device identifier (UDI) to confirm if your IceRod needle is affected.
The recall reports a trend of needle shaft gas leaks, which could potentially cause issues during medical procedures.
Check for batch numbers listed: U1440, U1441, U1311, U1312, U1015, U1016, U0462, U0461, U0050, U0030, T0520, T0521, T0157, T0158, A7135, A7134, A6987, A6986, A6707, A6708, A6689, A6688, A1730, A1731, A1149, A1150. Also look for unique device identifiers (UDIs) starting with 7290104830273.
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-0679-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0679-2021 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.
