Boston Scientific recalls IceFORCE 2.1 CX Prostate Cryoablation Kit with reported needle shaft gas leaks. Affected units have specific batch numbers and UDIs. Stop using immediately to prevent potential injury.
Complaint trend regarding needle shaft gas leaks.
Boston Scientific is recalling IceFORCE 2.1 CX Prostate Cryoablation Kits due to reported needle shaft gas leaks. This could lead to unintended medical complications during procedures. Affected units have specific batch numbers and unique device identifiers.
The recall is based on complaints about gas leaks in the needle shaft. These leaks could potentially cause unintended tissue damage or procedural complications during prostate cryoablation treatments.
Medical professionals using the IceFORCE 2.1 CX Prostate Cryoablation Kit for prostate procedures are most at risk. Patients receiving these procedures may also be affected if the kit is used improperly.
Check the batch numbers listed: U1030, U0904, U0864, U0856, U0763, U0649, T0153, A7062, A7061, A6930, A6758, A1781, A1776, A1565, A1550, A1435, A1291. Also look for the unique device identifiers (UDIs) starting with 7290104831034.
Discontinue use of the IceFORCE 2.1 CX Prostate Cryoablation Kit if it has the listed batch numbers or UDIs.
The recalled product is the IceFORCE 2.1 CX Prostate Cryoablation Kit.
Check the batch numbers listed: U1030, U0904, U0864, U0856, U0763, U0649, T0153, A7062, A7061, A6930, A6758, A1781, A1776, A1565, A1550, A1435, A1291. Also look for the unique device identifiers (UDIs) starting with 7290104831034.
Stop using the kit immediately and contact Boston Scientific 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-0682-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0682-2021 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.
