Boston Scientific recalls IceFORCE 2.1 CX L 90° Cryoablation Needles with reported gas leaks. Affected units have specific batch numbers and UDIs. Consumers should check their product details to determine if recalled.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceFORCE 2.1 CX L 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 issues during medical procedures. This is based on complaints about gas leaks in the needle shaft.
Medical professionals using the IceFORCE 2.1 CX L 90° cryoablation needles for procedures are most at risk. Patients using these needles for treatments may also be affected.
Check for the product name 'IceFORCE 2.1 CX L 90° Cryoablation Needle' with batch numbers listed in the recall notice. The unique device identifiers (UDIs) are 7290104831089.
Verify if your needle has the batch numbers listed in the recall notice: U1214, U1215, U1112, U1113, U0958, U0959, U0861, U0862, U0765, U0766, U0729, U0730, U0645, U0643, U0644, U0642, U0426, U0425, U0408, U0160, U0161, T0278, T0275, T0143, T0142, T0134, T0135, A7082, A7032, A7033, A6677, A6678, A2030, A2029, A1775, A1774, A1658, A1544, A1545, A1526, A1188, A1189.
The recall is based on complaints about gas leaks in the needle shaft, but no specific safety risks have been confirmed for normal use.
Check the batch numbers on your needle against the list provided in the recall notice: U1214, U1215, U1112, U1113, U0958, U0959, U0861, U0862, U0765, U0766, U0729, U0730, U0645, U0643, U0644, U0642, U0426, U0425, U0408, U0160, U0161, T0278, T0275, T0143, T0142, T0134, T0135, A7082, A7032, A7033, A6677, A6678, A2030, A2029, A1775, A1774, A1658, A1544, A1545, A1526, A1188, A1189.
The recall does not specify a remedy, so there is no action required beyond checking if your needle is affected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0659-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0659-2021 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.
