Boston Scientific recalls IceRod 1.5 PLUS Cryoablation Needles with reported gas leaks. Affected units have specific batch numbers and UDIs. Consumers should check their device details to determine if recalled.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceRod 1.5 PLUS Cryoablation Needles due to complaints about needle shaft gas leaks. This could potentially cause issues during medical procedures if the device leaks gas.
The needle shaft may leak gas, which could cause issues during medical procedures. This is based on complaints from users, but the exact risk level is not specified in the recall notice.
Medical professionals using the IceRod 1.5 PLUS Cryoablation Needle for procedures are likely affected. Patients receiving these procedures may be at risk if the device leaks gas.
Check for batch numbers U1021, U1022, U1014, U1013, U0780, U0781, U0391, U0214, U0008, A2081, A2080, or A1531. Also look for Unique Device Identifiers (UDIs) starting with 7290104830570.
Review the batch numbers and Unique Device Identifiers (UDIs) on your IceRod 1.5 PLUS Cryoablation Needle to see if it matches the recalled units.
The recall is based on complaints about needle shaft gas leaks, but the exact risk level is not specified in the notice.
Check the batch numbers (U1021, U1022, U1014, U1013, U0780, U0781, U0391, U0214, U0008, A2081, A2080, A1531) or Unique Device Identifiers (UDIs) starting with 7290104830570.
The recall notice 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-0667-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0667-2021 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.