Boston Scientific recalls IcePearl 2.1 CX Cryoablation Needles with reported gas leaks. Affected units have specific batch numbers and UDIs. Consumers should check their product details.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IcePearl 2.1 CX Cryoablation Needles due to reported gas leaks in the needle shaft. This could potentially cause issues during medical procedures, though the recall does not specify serious injury risks.
The needle shaft has reported gas leaks, which could lead to unintended effects during medical procedures. However, the recall does not indicate a risk of serious injury or death in normal use.
Medical professionals using the IcePearl 2.1 CX Cryoablation Needle for procedures are most likely affected. Patients using this device for treatments may also be impacted.
Check for batch numbers listed: U0902, U0786, U0646, U0558, U0041, T0269, T0137, T0138, T0056, T0025, A7015, A6929, A6908, A6723, A1564, A1521, A1249. Also look for the unique device identifiers (UDIs) starting with 7290104831010.
Review the batch numbers and unique device identifiers (UDIs) on your IcePearl 2.1 CX Cryoablation Needle to see if it matches the listed numbers.
The recall mentions reported gas leaks but does not specify a risk of serious injury or death in normal use, so it is considered low risk.
Check the batch numbers listed: U0902, U0786, U0646, U0558, U0041, T0269, T0137, T0138, T0056, T0025, A7015, A6929, A6908, A6723, A1564, A1521, A1249. Also look for UDIs starting with 7290104831010.
The recall does not provide a specific 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-0661-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0661-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
